To evaluate the clinical utility of the NaPi2b (67) Assay for use in the detection of NaPi2b in formalin-fixed, paraffin-embedded (FFPE) serous ovarian carcinoma tissue to determine patient eligibility for treatment with XMT-1536.
ID
Source
Brief title
Condition
- Reproductive neoplasms female benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Acceptance criteria are established by Mersana and analysis will be conducted
by Mersana.
Secondary outcome
N/A
Background summary
The purpose of this study is to prospectively screen formalin-fixed,
paraffin-embedded (FFPE) serous ovarian carcinoma tissue samples collected from
the Mersana Therapeutics study MER-XMT-1536-3 (UP-NEXT) with the NaPi2b (67)
Assay. This assay is being used to determine the NaPi2b status, a requirement
for determining patient eligibility in MER-XMT-1536-3 (UP-NEXT).
Study objective
To evaluate the clinical utility of the NaPi2b (67) Assay for use in the
detection of NaPi2b in formalin-fixed, paraffin-embedded (FFPE) serous ovarian
carcinoma tissue to determine patient eligibility for treatment with XMT-1536.
Study design
In this clinical utility study, the anonymized serous ovarian cancer samples
will be assessed for NaPi2b status, a requirement for determining patient
eligibility in Mersana UP-NEXT Study MER-XMT-1536-3.
Intervention
N/A
Study burden and risks
N/A
Balliol Business Park West Benton Lane
Newcastle Upon Tyne NE12 8EW
GB
Balliol Business Park West Benton Lane
Newcastle Upon Tyne NE12 8EW
GB
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83931.000.23 |