Prospective Clinical Utility Study for the NaPi2b (67) Assay in Serous Ovarian Cancer

• Conditions: ovarian cancer; 10038595

• Registration Number: NL-OMON53260
• Lead Sponsor: eica Biosystems Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

• FFPE tissue block or at least 3 FFPE tissue slides (1 for detecting NaPi2b
status, 1 for negative rabbit control, and 1 slide for H&E assessment) of 4-5
µm section thickness received from Mersana collection sites, collected
according to Mersana study MER-XMT-1536-3 (UP-NEXT).
• Surgical resections or core needle biopsies (FFPE)
Tissue preparation must meet all slide/sectioning requirements as detailed
within the NaPi2b (67) Assay IFU and BOND User Manual:
• Section Thickness (if slides): 4-5 µm
• Slides: Positively Charged, Leica BOND-III Compatible
• Fixative: Formalin Fixed

Exclusion Criteria

• Fine Needle Aspirate (FNA) and ascites samples prepared as FFPE cell blocks
• Cytology specimens (FNA, ascites, cell block)
• The specimen is collected at a site which is not covered under Mersana study
MER-XMT-1536-3 IRB/IEC review.
• The specimen is a repeat specimen from a patient whose sample has already
been included in the study.
• FFPE section thickness is not 4-5 µm
• Slides are not positively charged or are incompatible with BOND-III
• Tissue is not formalin-fixed

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Acceptance criteria are established by Mersana and analysis will be conducted<br /><br>by Mersana.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>N/A</p><br>