Molecular Ovarian Cancer Assessment in LatiNoAmerican PAtients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 320
- 试验地点
- 17
- 主要终点
- Percentage of high-grade serous advanced ovarian cancer (AOC) cases overlapping FRα, HER2, PD-L1 positive expression and aberration positives for HRD and BRCA.
研究概览
简要总结
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.
详细描述
The study combines a retrospective collection of clinical, sociodemographic, pathological, and treatment history data from medical records with a prospective laboratory analysis of archived tumor tissue samples collected between 2018 and 2024.
Biomarker Evaluation & Central Pathology:
Archival formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks or unstained slides will undergo centralized digital pathology review and immunohistochemical (IHC) evaluation to assess expression levels:
- Folate Receptor Alpha (FRa): Assessed using the Roche Ventana FOLR1 assay.
- HER2: Evaluated using the Roche Ventana HER2 (4B5) assay.
- PD-L1: Evaluated using Dako 22C3.
- Additional exploratory IHC markers (ER, PR, MLH1, MSH2, MSH6, PMS2) will also be evaluated.
Genetic and molecular status for BRCA1/2 mutations and Homologous Recombination Deficiency (HRD) obtained via Next-Generation Sequencing (NGS) will be extracted retrospectively from medical records as available in routine clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants ≥18 years-old.
- •Patients diagnosed with ovarian, fallopian tube or peritoneal cancer:
- •advanced stages stage III or IV by FIGO disease stage
- •new diagnosis and persistent or recurrent disease
- •Diagnosed from 2018 to
- •Histologically confirmed diagnosis of serous (low or high grade), endometrioid, mucinous or clear cell ovarian carcinoma.
- •Accept to participate in the project and sign the informed consent (if applicable).
- •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.
排除标准
- •Histological ambiguous diagnosis upon review.
- •Diagnosis based on cytology and without any biopsy or surgical specimen.
- •Patients diagnosed and staged but not receiving any treatment.
- •Patients without medical records available (lost, empty or irretrievable clinical information).
结局指标
主要结局
Percentage of high-grade serous advanced ovarian cancer (AOC) cases overlapping FRα, HER2, PD-L1 positive expression and aberration positives for HRD and BRCA.
时间窗: Data is extracted from retrospective medical records covering cases diagnosed from 2018 to 2024, with no prospective clinical follow-up or therapeutic interventions proposed.
The percentage of high- grade serous AOC cases which are overlapping FRα, HER2, PD-L1 positive expression by IHC according to established clinical cut-offs and aberration positives for HRD and BRCA: FRα: ≥75% of viable tumour cells with 2+ and 3+ scoring intensity. HER2: ≥10% of viable tumour cells with 3+ staining intensity by IHC using current CAP guidelines for scoring HER2 in gastric cancer. PD-L1: positive expression is combined positive score (CPS) ≥1 and ≥10. BRCA mutational status: mutated. HRD: positive.
次要结局
- Socio-demographic and clinicopathologic characteristics of Latin American advanced ovarian cancer (AOC) patients.(Baseline)
- Treatment patterns of high-grade serous advanced ovarian cancer (AOC).(Baseline)
- Folate receptor alpha (FRα), HER2, and PD-L1 expression by histologic advanced ovarian cancer (AOC) subtype.(Baseline)
- Mutational status of HRD and BRCA in high-grade serous advanced ovarian cancer (AOC).(Baseline)