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

Prospective Clinical Utility Study for the NaPi2b (67) Assay in Serous Ovarian Cancer - TSUNAMI UP-NEXT Clinical Utility Study Protocol

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53260

Enrollment

Registered

2023-06-05

Start date

2023-04-10

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ovarian cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Acceptance criteria are established by Mersana and analysis will be conducted by Mersana.	—

Countries

Netherlands

Outcome results