Molecular Ovarian Cancer Assessment in LatiNoAmerican PAtients

Molecular Ovarian Cancer Assessment in LatiNoAmerican PAtients

This is a multicentric observational study conducted at selected sites across Latin America. Eligible participants will be identified through the medical records of participating institutions. The study aims to describe overlap of expression of folate receptor alpha (FRα), HER2 and PD-L1 using immunohistochemistry (IHC) and HRD and BRCA (somatic and germline) by NGS. Additionally, to describe clinical demographic and socioeconomic variables, as well as treatment patterns, pathological characteristics, outcomes, and genetic and molecular testing part of clinical practice.

All data (including patient characteristics, treatment patterns, outcomes and available tests) will be collected once, retrospectively from medical records, ensuring adherence to ethical standards and participant confidentiality. Biomarkers analysis (including FRα, HER2 and PD-L1) will be performed prospectively, a Formalin-Fixed Paraffin-Embedded (FFPE) tumor block will be collected to evaluate and describe the expression of folate receptor alpha (FRα) and HER2, using immunohistochemistry (IHC) with the Roche Ventana kit (FOLR1 and HER2 4B5) and Dako's 22C3 for PD-L1. The study will analyze samples collected between 1st January 2018 to 31 December 2024 (analysis of historically collected samples).

The study comprises a retrospective data collection from medical charts. Participants will continue to receive treatment and clinical evaluations according to what is determined by their medical team, according to the usual standards of treatment and clinical practice of each center. No intervention or prospective follow-up is proposed in this study.

Inclusion Criteria:

1. Participants ≥18 years-old.

2. Patients diagnosed with ovarian, fallopian tube or peritoneal cancer:

   1. advanced stages stage III or IV by FIGO disease stage
   2. new diagnosis and persistent or recurrent disease

3. Diagnosed from 2018 to 2024.

4. Histologically confirmed diagnosis of serous (low or high grade), endometrioid, mucinous or clear cell ovarian carcinoma.

5. Accept to participate in the project and sign the informed consent (if applicable).

6. An archived representative formalin-fixed paraffin-embedded (FFPE) tumor specimen in tumor tissue blocks (preferred) or freshly sectioned unstained slides (at least 20) from biopsy/surgery is mandatory.

Exclusion Criteria:

1. Histological ambiguous diagnosis upon review.
2. Diagnosis based on cytology and without any biopsy or surgical specimen.
3. Patients diagnosed and staged but not receiving any treatment.
4. Patients without medical records available (lost, empty or irretrievable clinical information).