Clinical trial · Observational
FLABRA: Frontline Approach for BRCA Testing in OC Treatment naïve Population. A LATIN AMERICA Epidemiologic Study
Frontline Approach for BRCA Testing in OC Treatment naïve Population. A LATIN AMERICA Epidemiologic Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to answer very important questions regarding the prevalence of somatic and germline mutations (sBRCAm and gBRCAm) in a population of newly diagnosed ovarian cancer patients from Latin America. These answers may be extremely helpful in the counseling for genetic risk and treatment approach in these populations and will aid in making treatment decisions in the future
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Prevalence of BRCA 1 and BRCA 2 mutations in newly diagnosed ovarian cancer patients from Latinoamerican population
- timeFrame
- up to one year
- description
- FLABRA is a cross-sectional, multi-center, epidemiological observational study designed to evaluate the prevalence of BRCA mutations in newly diagnosed ovarian cancer patients across understudied ethnic groups in Latin America
Secondary outcomes (2)
- measure
- Prevalence of somatic and germline BRCA 1 and 2 mutations across Latinamerican population
- timeFrame
- up to one year
- description
- To estimate the prevalence of gBRCAm in newly diagnosed ovarian cancer patients who have a BRCA mutation identified in the tumor sample, in LATAM population, and by ethnic sub-groups
- measure
- Counselling approach in ovarian cancer across Latinamerican countries
- timeFrame
- up to one year
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclussion criteria: 1. Be able and willing to sign the informed consent form 2. Be older than 18 years of age 3. Have histologically confirmed new diagnosis of Federation of Gynecology and Obstetrics stage III or IV ovarian epithelial, primary peritoneal, or fallopian tube cancer made by one or more of the following: * standard staging laparotomy including bilateral salpingo-oophorectomy, omentectomy, and lymph node sampling and debulking and or * surgical resection and radiographic evidence consistent with Stage 3 or 4 ovarian cancer * paracentesis or biopsy with radiographic evidence consistent with Stage III or IV ovarian cancer (normal appearing pancreas, liver, and gastrointestinal tract) 4. Have availability of paraffin-embedded archived tumor tissue block (preferred) or, if a block is not possible, a minimum of twenty 10 microm sections 5. Have a diagnosis that is within 120 days of informed consent Exclusion criteria: 1. Have a diagnosis of any severe acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of the study results and, in the judgement of the Investigator, would make the patient inappropriate for enrollment in this study 2. Be a patient who, in the judgement of the Investigator, would be inappropriate for enrollment in this study
References
Publications (1)
- DERIVEDGiornelli G, Gallardo D, Hegg R, Abuin GG, La Vega M, Lim-Law M, Caceres V, Trujillo L, Pilar Estevez-Diz MD, Pacheco C, Sganga L, Goncalves S. FLABRA, frontline approach for BRCA testing in an ovarian cancer population: a Latin America epidemiologic study. Future Oncol. 2021 May;17(13):1601-1609. doi: 10.2217/fon-2020-1152. Epub 2021 Jan 8. PMID 33415992