FLABRA: Frontline Approach for BRCA Testing in OC Treatment naïve Population. A LATIN AMERICA Epidemiologic Study

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02984423
• Date of registration: 23/11/2016
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: FLABRA: Frontline Approach for BRCA Testing in OC Treatment naïve Population. A LATIN AMERICA Epidemiologic Study FLABRA
• Scientific title: Frontline Approach for BRCA Testing in OC Treatment naïve Population. A LATIN AMERICA Epidemiologic Study
• Date of first enrolment: December 27, 2016
• Target sample size: 471
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02984423
• Study type: Observational

Countries of recruitment

Argentina, Brazil, Colombia, Mexico, Panama, Peru

Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Ovarian Cancer

Primary Outcome(s)

Prevalence of BRCA 1 and BRCA 2 mutations in newly diagnosed ovarian cancer patients from Latinoamerican population [Time Frame: up to one year]

Secondary Outcome(s)

Counselling approach in ovarian cancer across Latinamerican countries [Time Frame: up to one year]

Prevalence of somatic and germline BRCA 1 and 2 mutations across Latinamerican population [Time Frame: up to one year]

Secondary ID(s)

D0817R00002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors