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Biomarker-Gyn-markers.html
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<!DOCTYPE html PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN" "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd">
<html>
<html xmlns="http://www.w3.org/1999/xhtml">
<head>
<meta http-equiv="Content-Type" content="text/html; charset=UTF-8">
<title>Gyn Biomarkers</title>
<link rel="stylesheet" type="text/css" href="view.css" media="all">
<script type="text/javascript" src="view.js"></script>
<script>
function updateDescription (frm)
{
var Template = ""
if (frm.A01.value !== ""){
Template += "- Estrogen receptor: " + frm.A01.value + "\n";
}
if (frm.A02.value !== ""){
Template += " - Average Intensity: " + frm.A02.value + "\n";
}
if (frm.A04.value !== ""){
Template += "- Progesterone receptor: " + frm.A04.value + "\n";
}
if (frm.A05.value !== ""){
Template += " - Average Intensity: " + frm.A05.value + "\n";
}
if (frm.A07.value !== ""){
Template += "- HER2/neu oncoprotein IHC: " + frm.A07.value + "\n";
}
if (frm.A08.value !== ""){
Template += " - Score : " + frm.A08.value + "\n";
}
if (frm.A09.value !== ""){
Template += "- HER2 DISH : " + frm.A09.value + "\n";
}
if (frm.A10.value !== ""){
Template += " - Number of tumor cell counted : " + frm.A10.value + "\n";
}
if (frm.A11.value !== ""){
Template += " - Average number of HER2 signals (black) per nucleus : " + frm.A11.value + "\n";
}
if (frm.A12.value !== ""){
Template += " - Average number of CEP17 signals (red) per nucleus : " + frm.A12.value + "\n";
}
if (frm.A13.value !== ""){
Template += " - HER2/CEP17 ratio : " + frm.A13.value + "\n";
}
if (document.getElementById("A14").checked || document.getElementById("A15").checked){
Template += " - Other ISH abnormalities: " + "\n";
}
if (document.getElementById("A14").checked){
Template += frm.A14.value + "\n";
}
if (document.getElementById("A15").checked){
Template += frm.A15.value + "\n";
}
if (frm.A27.value !== ""){
Template += "- p53 status : " + frm.A27.value + "\n";
}
if (frm.IHC.value !== ""){
Template += "- DNA Mismatch Repair status: " + "\n" + " - " + frm.IHC.value + "\n";
}
if (frm.MLH1.value !== ""){
Template += " - MLH1 (mutL homolog 1): " + frm.MLH1.value + "\n";
}
if (frm.MSH2.value !== ""){
Template += " - MSH2 (mutS homolog 2): "+ frm.MSH2.value + "\n";
}
if (frm.MSH6.value !== ""){
Template += " - MSH6 (mutS homolog 6): " + frm.MSH6.value + "\n";
}
if (frm.PMS2.value !== ""){
Template += " - PMS2 (PMS1 homolog 2): " + frm.PMS2.value + "\n";
}
if (document.getElementById("A30").checked){
Template += frm.A30.value + "\n";
}
if (frm.MSI.value !== ""){
Template += "\n" + "- Microsatellite instability status: " + "\n" + " - " + frm.MSI.value + "\n";
}
if (frm.BAT25.value + frm.BAT26.value + frm.NR21.value + frm.NR24.value + frm.NR27.value!== ""){
Template += " - Mononucleotide Panel: " + "\n";
}
if (frm.BAT25.value !== ""){
Template += " - BAT-25 : " + frm.BAT25.value + "\n";
}
if (frm.BAT26.value !== ""){
Template += " - BAT-26 : " + frm.BAT26.value + "\n";
}
if (frm.NR21.value !== ""){
Template += " - NR-21 : " + frm.NR21.value + "\n";
}
if (frm.NR24.value !== ""){
Template += " - NR-24 : " + frm.NR24.value + "\n";
}
if (frm.NR27.value !== ""){
Template += " - NR-27 : " + frm.NR27.value + "\n";
}
if (frm.BAT25.value + frm.BAT26.value + frm.D2.value + frm.D5.value + frm.D17.value!== ""){
Template += "\n" + " - NCI Panel: " + "\n";
}
if (frm.BAT25.value !== ""){
Template += " - BAT-25 : " + frm.BAT25.value + "\n";
}
if (frm.BAT26.value !== ""){
Template += " - BAT-26 : " + frm.BAT26.value + "\n";
}
if (frm.D2.value !== ""){
Template += " - D2S123 : " + frm.D2.value + "\n";
}
if (frm.D5.value !== ""){
Template += " - D5S346 : " + frm.D5.value + "\n";
}
if (frm.D17.value !== ""){
Template += " - D17S250 : " + frm.D17.value + "\n";
}
if (frm.A20.value !== ""){
Template += "- PD-L1 : "+ frm.A20.value + "\n";
}
if (frm.A23.value !== ""){
Template += " - Combined Positive Score CPS : "+ frm.A23.value + "\n";
}
if (frm.A31.value !== ""){
Template += "- Folate Receptor Alpha Status : " + frm.A31.value + "\n";
}
if (frm.A32.value !== ""){
Template += "- Test type : " + frm.A32.value + "\n";
}
if (frm.A19.value !== ""){
Template += "\n" + "- Additional notes: " + "\n" + " - " + frm.A19.value + "\n";
}
if (frm.A01.value + frm.A04.value !== ""){
Template += "\n" + "Formalin-fixed paraffin embedded sections were assessed by IHC technique for ER and PR, using Novocastra ER (clone: 6F11) and Dako PR (clone: PgR636) with the Bond polymer refined detection system." + "\n";
}
if (frm.A07.value !== ""){
Template += "\n" + "Formalin-fixed paraffin embedded sections were assessed by IHC technique for HER2, using Ventana monoclonal HER2/neu (4B5) with Ventana BenchMark ULTRA multimer detection system." + "\n";
};
if (frm.A09.value !== ""){
Template += "\n" + "HER2 Dual ISH was performed on formalin-fixed paraffin embedded section with the Ventana INFORM HER2 Dual ISH DNA Probe Cocktail Assay on automated system, and examined by a pathologist under light microscopy." + "\n";
}
if (frm.IHC.value !== ""){
Template += "\n"+ "Antibodies for MLH1, MSH2, MSH6 and PMS2 are G168-15, FE11, 44/MSH6 and A16-4, respectively." + "\n";
}
if (frm.MSI.value !== ""){
Template += "\n" + "DNA was extracted from the tumor tissue and the normal tissue, following microdissection of formalin-fixed paraffin-embedded tissue sections. MSI was assessed using a laboratory developed method by comparing the differences in patterns of PCR products of 5 mononucleotide repeats and 3 dinucleotide repeats markers of the tumor tissue and those of the normal tissue. The MSI test is under evaluation and is not in the CAP-acredited list." + "\n";
}
if (frm.A20.value !== ""){
Template += "\n" + "Formalin-fixed paraffin embedded sections were assessed by IHC technique for PD-L1, using the antibody " + frm.A21.value + ". " + "\n";
}
if (frm.A28.value !== ""){
Template += "\n" + "- Cold ischemia time : " + frm.A28.value + " min";
} else {
Template += "\n" + "- Cold ischemic time is uncertain." ;
}
if (frm.A28.value <= 60 && frm.A28.value !== ""){
Template += "\n" + " - Optimal (<= 60 min)." ;
}
if (frm.A28.value > 60 && frm.A28.value !== ""){
Template += "\n" + " - Prolonged intervals (> 60 min)." ;
}
if (frm.A29.value !== ""){
Template += "\n" + "- Fixation time in buffered formalin : " + frm.A29.value + " hours";
}else {
Template += "\n" + "- Formalin fixation time is uncertain." ;
}
if (frm.A29.value < 6 && frm.A29.value !== ""){
Template += "\n" + " - Inadequate fixation (<6 hours)." ;
}
if (frm.A29.value >= 6 && frm.A29.value <= 72 && frm.A29.value !== ""){
Template += "\n" + " - Optimal fixation (6-72 hours)." ;
}
if (frm.A29.value > 72 && frm.A29.value !== ""){
Template += "\n" + " - Prolonged intervals (>72 hours)." ;
}
if (frm.A28.value !== "" && frm.A28.value <= 60 && frm.A29.value >= 6 && frm.A29.value <= 72){
Template += "\n" + "- Meet requirements specified in the latest version of the ASCO/CAP guidelines." + "\n" ;
} else if (frm.A28.value == "" || frm.A29.value == ""){
Template += "\n" + "- Given the uncertain cold ischaemia time and/or uncertain fixation time, please interpret the above results with caution." + "\n" ;
} else if (frm.A28.value > 60 || frm.A29.value < 6 || frm.A29.value > 72){
Template += "\n" + "- Given the suboptimal cold ischaemia time and/or suboptimal formalin fixation time, please interpret the above results with caution." + "\n" ;
}
frm.holdtext.value = Template;
}
function CopyToClipboard() {
/* Get the text field */
var copyText = document.getElementById("holdtext");
/* Select the text field */
copyText.select();
/* Copy the text inside the text field */
document.execCommand("copy");
/* Alert the copied text */
alert("Report copied to clipboard");
}
</script>
<style>
table, th, td {
border: 1px solid silver;
border-collapse: collapse;
padding: 4px;
}
</style>
</head>
<body>
<img id="top" src="top.png" alt="">
<div id="form_container">
<div class="form_description">
<h2>
<a href=".\cap\Cancer-Protocols-2024-12-Update\Gynecologic Protocol Folder\Gynecologic.Bmk_1.2.0.0. REL.CAPCP.pdf" target="_blank">
<div class="tooltip">Gynecologic biomarkers testing
<span class="tooltiptext">click to access further explanations in the original CAP template</span>
</div>
</a></h2>
</div>
<form>
<p>
<fieldset style="border-color:#e6e6ff;">
<legend> <label class="description"> Hormonal receptors : </label></legend>
<p>
- For ER/PR, POSITIVE is >= 1%<br>
</p>
<p>
<table border="1">
<col width="40%">
<tr>
<td rowspan="2" valign="top">
<label class="description">- Estrogen recepter (ER) IHC :</label>
</td>
<td>
<select class="element select large" ID="A01">
<option value=""></option>
<option value="Cannot be determined">Cannot be determined</option>
<option value="Negative, Internal control cells present and stain as expected">Negative, Internal control cells present and stain as expected</option>
<option value="Negative, Internal control cells absent">Negative, Internal control cells absent</option>
<option value="Negative, other (specify):">Negative, other (specify):</option>
<option value="Positive (>1% positive nuclei)">Positive (>=1% positive nuclei)</option>
</select>
</td>
</tr>
<tr>
<td align="right">
<label>- Average Intensity :</label>
<select class="element select medium" ID="A02">
<option value=""></option>
<option value="Negative (0)">Negative (0)</option>
<option value="Weak staining (1)">Weak staining (1)</option>
<option value="Moderate staining (2)">Moderate staining (2)</option>
<option value="Strong staining (3)">Strong staining (3)</option>
</select>
</td>
</tr>
<tr>
<td rowspan="2" valign="top">
<label class="description">- Progesterone recepter (PR) IHC :</label>
</td>
<td>
<select class="element select large" ID="A04">
<option value=""></option>
<option value="Cannot be determined">Cannot be determined</option>
<option value="Negative, Internal control cells present and stain as expected">Negative, Internal control cells present and stain as expected</option>
<option value="Negative, Internal control cells absent">Negative, Internal control cells absent</option>
<option value="Negative, other (specify):">Negative, other (specify):</option>
<option value="Positive (>1% positive nuclei)">Positive (>=1% positive nuclei)</option>
</select>
</td>
</tr>
<tr>
<td align="right">
<label>- Average Intensity :</label>
<select class="element select medium" ID="A05">
<option value=""></option>
<option value="Negative (0)">Negative (0)</option>
<option value="Weak staining (1)">Weak staining (1)</option>
<option value="Moderate staining (2)">Moderate staining (2)</option>
<option value="Strong staining (3)">Strong staining (3)</option>
</select></td>
</tr>
</table>
</fieldset>
</p>
<p>
<fieldset style="border-color:#e6e6ff;">
<legend> <label class="description"> HER2 status : </label></legend>
<p>
<table border="1">
<col width="40%">
<tr>
<td rowspan="2" valign="top">
<label class="description">- HER2/neu oncoprotein IHC :</label>
Low-power, observed within a homogeneous and contiguous population of invasive tumor cells.
</td>
<td><select class="element select large" ID="A07">
<option value=""></option>
<option value="Cannot be determined">Cannot be determined</option>
<option value="Negative for over-expression">Negative for over-expression</option>
<option value="Equivocal for over-expression">Equivocal for over-expression</option>
<option value="Positive for over-expression">Positive for over-expression</option>
</select>
</td>
</tr>
<tr>
<td align="right">
<label>- Score (see below) :</label>
<select class="element select medium" ID="A08">
<option value=""></option>
<option value="0 ">0 </option>
<option value="1 ">1 </option>
<option value="2 ">2 </option>
<option value="3 ">3 </option>
</select>
</td>
</tr>
</table>
</p>
<p>
<fieldset style="border-color:#e6e6ff;">
<legend> <label class="description">HER2 Scoring System : </label></legend>
Based on the enrollment criteria for Trastuzumab in the randomized phase II clinical trial NCT01367002 for endometrial carcinoma HER2 Status for Trastuzumab Use <br>
<br>
<b>Negative (score 0) for protein overexpression</b><br>
No staining in tumor cells<br><br>
<b>Negative (score 1+) for protein overexpression</b><br>
Faint / barely perceptible, incomplete membrane staining in any proportion, or weak complete staining in less than 10% of tumor cells<br><br>
<b>Equivocal (score 2+) for protein overexpression</b><br>
Strong complete or basolateral / lateral membrane staining in less than or equal to 30%, or weak to moderate staining in greater than or equal to 10% of tumor cells<br><br>
<b>Positive (3+) for protein overexpression</b><br>
Strong complete or basolateral / lateral membrane staining in greater than 30% of tumor cells<br><br><br>
</fieldset>
</p>
<p>
<fieldset style="border-color:#e6e6ff;">
<legend> <label class="description">HER2 Status for Trastuzumab-deruxtecan Use : </label></legend>
<b>Negative (score 0) for protein overexpression</b><br>
<b>Biopsy</b>: No staining in any tumor cells;<br>
<b>Surgical specimen</b>: No staining or membrane staining in less than 10% of tumor cells<br><br>
<b>Negative (score 1+) for protein overexpression</b><br>
<b>Biopsy</b>: Tumor cell cluster (5 or more tumor cells) with a faint / barely perceptible membrane staining irrespective of percentage of positive tumor cells;<br>
<b>Surgical specimen</b>: Faint / barely perceptible incomplete membrane staining in greater than or equal to 10% tumor cells<br><br>
<b>Equivocal (score 2+) for protein overexpression</b><br>
<b>Biopsy</b>: Tumor cell cluster (5 or more tumor cells) with a weak to moderate, complete, basolateral or lateral membrane staining irrespective of percentage of positive tumor cells;<br>
<b>Surgical specimen</b>: Weak to moderate, complete, basolateral or lateral membrane staining in greater than or equal to 10% of tumor cells<br><br>
<b>Positive (3+) for protein overexpression</b><br>
<b>Biopsy</b>: Tumor cell cluster (5 or more tumor cells) with a strong, complete, basolateral or lateral membrane staining irrespective of percentage of positive tumor cells;<br>
<b>Surgical specimen</b>: Strong, complete, basolateral or lateral membrane staining in greater than or equal to 10% of tumor cells<br><br><br>
</fieldset>
</p>
<p>
<table border="1">
<col width="40%">
<tr><td rowspan="6" valign="top">
<label">+ HER2/neu oncoprotein DISH :</label>
<br><a href=".\Biomarker-DISH-calculator.html" target="_blank">HER2 DISH calculator</a>
<br>
<br>
<br> NEGATIVE: FISH HER2/CEP17 ratio less than 2.0 and Average HER2 copy number < 6/nucleus
<br> POSITIVE: FISH HER2/CEP17 ratio greater than or equal to 2.0 OR FISH HER2/CEP17 ratio less than 2.0 with average HER2 copy number >= 6/nucleus
</td>
<td><select class="element select large" ID="A09">
<option value=""></option>
<option value="Cannot be determined">Cannot be determined</option>
<option value="Negative for HER2 amplification">Negative for HER2 amplification</option>
<option value="Positive for HER2 amplification">Positive for HER2 amplification</option>
</select></td>
</tr>
<tr><td align="right">
- Number of tumor cells counted :
<input type="text" class="element text small" ID="A10" size="10"></td>
</tr>
<tr><td align="right">
- Average HER2 signals (black) per nucleus :
<input type="text" class="element text small" ID="A11" size="10"></td>
</tr>
<tr><td align="right">
- Average CEP17 signals (red) per nucleus :
<input type="text" class="element text small" ID="A12" size="10"></td>
</tr>
<tr><td align="right">
- HER2/CEP17 ratio :
<input type="text" class="element text small" ID="A13" size="10"></td>
</tr>
<tr>
<td>- Other ISH abnormalities:<br>
<input class="element checkbox" type="checkbox" id="A14" value=" - Aneusomy"><label class="choice">Aneusomy</label>
<input class="element checkbox" type="checkbox" id="A15" value=" - Heterogeneous signals"><label class="choice">Heterogeneous signals</label>
</td>
</tr>
</table>
</p>
</fieldset>
</p>
<p>
<fieldset style="border-color:#e6e6ff;">
<legend> <label class="description"> DNA mismatch repair status : </label></legend>
<table border="1">
<col width="40%">
<tr>
<td rowspan="6" valign="top">
<label class="description">- MMR IHC:</label>
</td>
<td>
<select class="element select large" ID="IHC">
<option value=""></option>
<option value="No loss of nuclear signals of all 4 proteins: Not defective in DNA mismatch repair (non-dMMR or MMRp) and low probability of microsatellite instability-high (MSI-H).">No loss of nuclear signals of all 4 proteins: Not defective in DNA mismatch repair (non-dMMR or MMRp) and low probability of microsatellite instability-high (MSI-H).</option>
<option value="Loss of nuclear signals of 1 or more proteins: Defective DNA mismatch repair within the tumor (dMMR). Causes could be somatic mutation or DNA methylation (sporadic), or germline alteration (Lynch syndrome).">Loss of nuclear signals of 1 or more proteins: Defective DNA mismatch repair within the tumor (dMMR). </option>
<option value="Loss of nuclear expression of MLH1 and PMS2: testing for methylation of the MLH1 promoter is indicated (the presence of MLH1 methylation suggests that the tumor is sporadic and germline evaluation is probably not indicated; absence of MLH1 promoter methylation suggests the possibility of Lynch syndrome, and sequencing and / or large deletion / duplication testing of germline MLH1 is indicated)">Loss of nuclear expression of MLH1 and PMS2: testing for methylation of the MLH1 promoter is indicated (the presence of MLH1 methylation suggests that the tumor is sporadic and germline evaluation is probably not indicated; absence of MLH1 promoter methylation suggests the possibility of Lynch syndrome, and sequencing and / or large deletion / duplication testing of germline MLH1 is indicated).</option>
<option value="Loss of nuclear expression of MSH2 and MSH6: high probability of Lynch syndrome, genetic counseling is recommended.">Loss of nuclear expression of MSH2 and MSH6: high probability of Lynch syndrome, genetic counseling is recommended. </option>
<option value="Loss of nuclear expression of MSH6 only: high probability of Lynch syndrome, genetic counseling is recommended.">Loss of nuclear expression of MSH6 only: high probability of Lynch syndrome, genetic counseling is recommended. </option>
<option value="Loss of nuclear expression of PMS2 only: high probability of Lynch syndrome, genetic counseling is recommended.">Loss of nuclear expression of PMS2 only: high probability of Lynch syndrome, genetic counseling is recommended.</option>
<option value="Subclonal loss of nuclear expression of MMR protein(s) (specify):">Subclonal loss of nuclear expression of MMR protein(s) (specify):</option>
<option value="Other (specify):">Other (specify):</option>
<option value="MMR status cannot be determined by IHC.">MMR status cannot be determined by IHC.</option>
</select>
</td>
</tr>
<tr>
<td align="right" >
<label class="">- MLH1 (mutL homolog 1):</label>
<select class="element select medium" ID="MLH1">
<option value=""></option>
<option value="Intact nuclear expression in tumor cells">Intact nuclear expression in tumor cells</option>
<option value="Loss of nuclear expression in tumor cells">Loss of nuclear expression in tumor cells</option>
<option value="Subclonal loss in the tumor cells">Subclonal loss in the tumor cells</option>
<option value="Attenuated nuclear expression in tumor cells">Attenuated nuclear expression in tumor cells</option>
<option value="Other (specify):">Other (specify):</option>
<option value="Cannot be determined:">Cannot be determined:</option>
</select></td >
</tr>
<tr>
<td align="right"><label class="">- PMS2 (PMS1 homolog 2):</label>
<select class="element select medium" ID="PMS2">
<option value=""></option>
<option value="Intact nuclear expression in tumor cells">Intact nuclear expression in tumor cells</option>
<option value="Loss of nuclear expression in tumor cells">Loss of nuclear expression in tumor cells</option>
<option value="Subclonal loss in the tumor cells">Subclonal loss in the tumor cells</option>
<option value="Attenuated nuclear expression in tumor cells">Attenuated nuclear expression in tumor cells</option>
<option value="Other (specify):">Other (specify):</option>
<option value="Cannot be determined:">Cannot be determined:</option>
</select></td >
</tr>
<tr>
<td align="right"><label class="">- MSH2 (mutS homolog 2):</label>
<select class="element select medium" ID="MSH2">
<option value=""></option>
<option value="Intact nuclear expression in tumor cells">Intact nuclear expression in tumor cells</option>
<option value="Loss of nuclear expression in tumor cells">Loss of nuclear expression in tumor cells</option>
<option value="Subclonal loss in the tumor cells">Subclonal loss in the tumor cells</option>
<option value="Attenuated nuclear expression in tumor cells">Attenuated nuclear expression in tumor cells</option>
<option value="Other (specify):">Other (specify):</option>
<option value="Cannot be determined:">Cannot be determined:</option>
</select></td >
</tr>
<tr>
<td align="right"><label class="">- MSH6 (mutS homolog 6):</label>
<select class="element select medium" ID="MSH6">
<option value=""></option>
<option value="Intact nuclear expression in tumor cells">Intact nuclear expression in tumor cells</option>
<option value="Loss of nuclear expression in tumor cells">Loss of nuclear expression in tumor cells</option>
<option value="Subclonal loss in the tumor cells">Subclonal loss in the tumor cells</option>
<option value="Attenuated nuclear expression in tumor cells">Attenuated nuclear expression in tumor cells</option>
<option value="Other (specify):">Other (specify):</option>
<option value="Cannot be determined:">Cannot be determined:</option>
</select></td >
</tr>
<tr>
<td><input class="element checkbox" type="checkbox" id="A30" value=" - Background non-neoplastic tissue / internal control shows intact nuclear expression"><label class="choice">+ Background non-neoplastic tissue / internal control shows intact nuclear expression.</label></td>
</tr>
<tr>
<td rowspan="9" valign="top"><label class="">+ MSI status:</label>
<br>
<br>
<br>
*Note that hereditary colon cancer clinic is using slightly different markers for MSI. Six mononucleotide repeat (BAT25, BAT26, SLC7A8 (NR-21), TMPPB5 (NR-22), ZNF-2 (NR-24) and BAT40), and three dinucleotide repeats (D2S123, D5S346, D17S250).</td>
<td><select class="element select large" ID="MSI">
<option value=""></option>
<option value="MSI - stable (MSS)">MSI – stable (MSS)</option>
<option value="MSI - low (MSI-L) 1% - 29% of the National Cancer Institute (NCI) or mononucleotide markers exhibit instability">MSI – low (MSI-L) 1% - 29% of the National Cancer Institute (NCI) or mononucleotide markers exhibit instability</option>
<option value="MSI - low (MSI-L) 1 of the NCI or mononucleotide markers exhibit instability">MSI – low (MSI-L) 1 of the NCI or mononucleotide markers exhibit instability</option>
<option value="MSI - low (MSI-L) Other (specify): ">MSI – low (MSI-L) Other (specify):</option>
<option value="MSI - high (MSI-H) greater or equal 30% of the NCI or mononucleotide markers exhibit instability">MSI – high (MSI-H) greater or equal 30% of the NCI or mononucleotide markers exhibit instability</option>
<option value="MSI - high (MSI-H) 2 or more of the NCI or mononucleotide markers exhibit instability">MSI – high (MSI-H) 2 or more of the NCI or mononucleotide markers exhibit instability</option>
<option value="MSI - high (MSI-H) Other (specify): ">MSI – high (MSI-H) Other (specify):</option>
<option value="MSI - cannot be determined.">MSI - cannot be determined.</option>
</select></td>
</tr>
<tr>
<td align="right"><label class="">BAT-25:</label>
<select class="element select medium" ID="BAT25">
<option value=""></option>
<option value="Stable">Stable</option>
<option value="Unstable">Unstable</option>
<option value="Cannot be determined:">Cannot be determined:</option>
<option value="Not performed">Not performed</option>
</select>
</td></tr>
<tr>
<td align="right"><label class="">BAT-26:</label>
<select class="element select medium" ID="BAT26">
<option value=""></option>
<option value="Stable">Stable</option>
<option value="Unstable">Unstable</option>
<option value="Cannot be determined:">Cannot be determined:</option>
<option value="Not performed">Not performed</option>
</select>
</td ></tr>
<tr>
<td align="right"><label class="">NR-21:</label>
<select class="element select medium" ID="NR21">
<option value=""></option>
<option value="Stable">Stable</option>
<option value="Unstable">Unstable</option>
<option value="Cannot be determined:">Cannot be determined:</option>
<option value="Not performed">Not performed</option>
</select>
</td ></tr>
<tr>
<td align="right"><label class="">NR-24 :</label>
<select class="element select medium" ID="NR24">
<option value=""></option>
<option value="Stable">Stable</option>
<option value="Unstable">Unstable</option>
<option value="Cannot be determined:">Cannot be determined:</option>
<option value="Not performed">Not performed</option>
</select>
</td ></tr>
<tr>
<td align="right"><label class="">NR-27 :</label>
<select class="element select medium" ID="NR27">
<option value=""></option>
<option value="Stable">Stable</option>
<option value="Unstable">Unstable</option>
<option value="Cannot be determined:">Cannot be determined:</option>
<option value="Not performed">Not performed</option>
</select>
</td ></tr>
<tr>
<td align="right"><label class="">D2S123:</label>
<select class="element select medium" ID="D2">
<option value=""></option>
<option value="Stable">Stable</option>
<option value="Unstable">Unstable</option>
<option value="Cannot be determined:">Cannot be determined:</option>
<option value="Not performed">Not performed</option>
</select>
</td ></tr>
<tr>
<td align="right"><label class="">D5S346:</label>
<select class="element select medium" ID="D5">
<option value=""></option>
<option value="Stable">Stable</option>
<option value="Unstable">Unstable</option>
<option value="Cannot be determined:">Cannot be determined:</option>
<option value="Not performed">Not performed</option>
</select>
</td ></tr>
<tr>
<td align="right"><label class="">D17S250:</label>
<select class="element select medium" ID="D17">
<option value=""></option>
<option value="Stable">Stable</option>
<option value="Unstable">Unstable</option>
<option value="Cannot be determined:">Cannot be determined:</option>
<option value="Not performed">Not performed</option>
</select>
</td ></tr>
</table>
</fieldset>
</p>
<p>
<table border="1">
<col width="40%">
<tr>
<td>
<label class="description">- p53 IHC:</label>
</td>
<td>
<select class="element select large" ID="A27">
<option value=""></option>
<option value="Normal (wild type) expression.">Normal (wild type) expression.</option>
<option value="Abnormal (mutated) expression">Abnormal (mutated) expression.</option>
<option value="Abnormal, Overexpression (strong, diffuse basilar nuclear expression)">Abnormal, Overexpression (strong, diffuse basilar nuclear expression, >90%)</option>
<option value="Abnormal, Null (lack of nuclear or cytoplasmic expression, internal positive control present)">Abnormal, Null (lack of nuclear or cytoplasmic expression, internal positive control present)</option>
<option value="Abnormal, Cytoplasmic only (lacks nuclear expression)">Abnormal, Cytoplasmic only (lacks nuclear expression)</option>
<option value="Subclonal abnormal (mutated)">Subclonal abnormal (mutated)</option>
<option value="Subclonal abnormal, Overexpression (strong, diffuse basilar nuclear expression)">Subclonal abnormal, Overexpression (strong, diffuse basilar nuclear expression, >90%)</option>
<option value="Subclonal abnormal, Null (lack of nuclear or cytoplasmic expression, internal positive control present)">Subclonal abnormal, Null (lack of nuclear or cytoplasmic expression, internal positive control present)</option>
<option value="Subclonal abnormal, Cytoplasmic only (lacks nuclear expression)">Subclonal abnormal, Cytoplasmic only (lacks nuclear expression)</option>
<option value="Other (specify):">Other (specify):</option>
<option value="Cannot be determined (explain):">Cannot be determined (explain):</option>
</select>
</td>
</tr>
<tr>
<td>
</td>
</tr>
<tr>
<td rowspan="3" valign="top">
<label class="">+ <a href=".\cap\PD-L1 Interpretation Guide.pdf" target="_blank">PD-L1 assessment</a> :</label><br>
<a href=".\Biomarker-PDL1-calculator.html" target="_blank">PD-L1 calculator</a><br>
Please specify if alternate scoring system was used.<br>
CPS = Total positive cells / (Positive cells + Negative tumor cells). CPS >=1 is POSITIVE.<br>
</td>
<td>
<select class="element select large" ID="A20">
<option value=""></option>
<option value="Cannot be determined">Cannot be determined</option>
<option value="Negative (<1% positive cells)">Negative (combined positive score CPS < 1)</option>
<option value="Positive (combined positive score CPS > or = 1)">Positive (combined positive score CPS > or = 1)</option>
<option value="Other (specify):">Other (specify):</option>
</select>
</td>
</tr>
<tr>
<td align="right">
<label>- Antibody (anti-CD274) :</label>
<select class="element select small" ID="A21">
<option value=""></option>
<option value="22C3 (Dako)">22C3 (Dako)</option>
<option value="E1L3N (Cell Signaling)">E1L3N (Cell Signaling)</option>
<option value="Other, specify:">Other, specify:</option>
</select>
</td>
</tr>
<tr>
<td align="right"><label>- Combined Positive Score (CPS) :</label>
<input type="text" class="element text small" ID="A23" size="35"></td>
</tr>
<tr>
<td>
</td>
</tr>
<tr>
<td>
<label class="">+ Folate receptor alpha status:</label>
</td>
<td>
<select class="element select large" ID="A31">
<option value=""></option>
<option value="Positive (greater than or equal to 75% viable tumor cells with moderate to strong membrane staining).">Positive (greater than or equal to 75% viable tumor cells with moderate to strong membrane staining).</option>
<option value="Negative (less than 75% of viable tumor cells with moderate to strong membrane staining, weak staining in any proportion of tumor cells or no staining)">Negative (less than 75% of viable tumor cells with moderate to strong membrane staining, weak staining in any proportion of tumor cells or no staining)</option>
<option value="Cannot be evaluated (artifacts precluding interpretation):">Cannot be evaluated (artifacts precluding interpretation):</option>
<option value="Other (specify):">Other (specify):</option>
</select>
</td>
</tr>
<tr>
<td>
</td>
</tr>
<tr>
<td>
<label class="description">- Cold ischemia time (min) :</label>
</td>
<td>
<input type="text" class="element text small" ID="A28" size="1">
min
</td>
<tr>
<td>
<label class="description">- Fixation time in buffered formalin :</label>
</td>
<td>
<input type="text" class="element text small" ID="A29" size="1">
hours
</td>
</tr>
<tr>
<td>
</td>
</tr>
<tr>
<td>
<label class="">+ Test type :</label>
</td>
<td>
<select class="element select large" ID="A32">
<option value=""></option>
<option value="Food and Drug Administration (FDA) cleared (specify test / vendor):">Food and Drug Administration (FDA) cleared (specify test / vendor):</option>
<option value="Laboratory-developed test (QMH, HK).">Laboratory-developed test.</option>
<option value="Other (specify):">Other (specify):</option>
</select>
</td>
</table>
</p>
<p>
<img src=".\cap\PD-L1_percentage_estimation.png" alt="Positive percentage" width="600"><br>
(from Roche document SP263 manual)
</p>
<p>
+ Ancillary studies include <a href="Biomarker-NGS.html" target="_blank">BRCA1 and BRCA2 germline and somatic mutation testings</a> and <a href="Biomarker-PCR.html" target="_blank">POLE hot spot mutations</a>
</p>
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<textarea ID="A19" class = "element textarea medium" style="border-color:grey;"></textarea>
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Last upated 30-Dec-2024, based on <a href=".\cap\Cancer-Protocols-2023-03-Update\Gynecologic Protocol Folder\Gynecologic.Bmk_1.1.0.0.REL_CAPCP.pdf" target="_blank"> Gynecologic Biomarkers 1.2.0.0 Dec-2024</a>.<br>
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