FLABRA: Frontline Approach for BRCA Testing in OC Treatment naïve Population. A LATIN AMERICA Epidemiologic Study
NCT ID: NCT02984423
Last Updated: 2020-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
471 participants
OBSERVATIONAL
2016-12-27
2019-06-30
Brief Summary
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Detailed Description
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In the Screening Visit, consecutive eligible patients who have been newly diagnosed with ovarian cancer within the last 120 days will be invited to participate. After having provided consent, patients will be asked to provide ethnicity and cancer family history information. Patients will self-identify to one or more of the defined broad ethnic groups (Native American, Afro-Caribbean, Caucasian) based on self-reported ancestry information. Archived tumor blocks or twenty 10-µm sections from eligible patients will be requested from the local pathology lab and used for BRCA mutations testing.
Patient medical records will be reviewed for data relevant to the ovarian cancer diagnosis, including basic demographics, medical history, and treatment history.
During the Devolution Visit, results of the tumor BRCA test will be communicated to the patient, and information about counselling approach and treatment plan will be recorded in the medical chart. This Devolution Visit will be the last visit for this study for the cases of non-mutated patients. For patients for whom a BRCA mutation have been identified in tumor, additional test in blood looking for the specific point mutation found in tumor will be performed to investigate if these patients harbor a germline BRCA mutation. For these patients a further visit will be organised to communicate results to the patient and data regarding germline test results will be recorded in the medical chart of the patient.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Exclusion Criteria
2. Be a patient who, in the judgement of the Investigator, would be inappropriate for enrollment in this study
FEMALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Buenos Aires, , Argentina
Research Site
Buenos Aires, , Argentina
Research Site
CABA, , Argentina
Research Site
Córdoba, , Argentina
Research Site
La Rioja, , Argentina
Research Site
Resistencia, , Argentina
Research Site
Rosario, , Argentina
Research Site
Barretos, , Brazil
Research Site
Belo Horizonte, , Brazil
Research Site
Curitiba, , Brazil
Research Site
Fortaleza, , Brazil
Research Site
Fortaleza, , Brazil
Research Site
Jaú, , Brazil
Research Site
Porto Alegre, , Brazil
Research Site
Rio de Janeiro, , Brazil
Research Site
Rio de Janeiro, , Brazil
Research Site
Salvador, , Brazil
Research Site
São Paulo, , Brazil
Research Site
São Paulo, , Brazil
Research Site
Bogotá, , Colombia
Research Site
Cali, , Colombia
Research Site
Medellín, , Colombia
Research Site
México, , Mexico
Research Site
Panama City, , Panama
Research Site
Lima, , Peru
Research Site
Lima, , Peru
Research Site
San Isidro, , Peru
Countries
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References
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Giornelli 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.
Related Links
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Other Identifiers
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D0817R00002
Identifier Type: -
Identifier Source: org_study_id
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