Clinical trial NCT02984423: FLABRA: Frontline Approach for BRCA Testing in OC Treatment naïve Population. A LATIN AMERICA Epidemiologic Study
Official title: Frontline Approach for BRCA Testing in OC Treatment naïve Population. A LATIN AMERICA Epidemiologic Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer
BRCA mutations
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2016-12-07
Enrollment: 471
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed patients with (FIGO) stage III or IV ovarian epithelial, primary peritoneal, or fallopian tube cancer made

Brief summary: 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

Detailed 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 objectives of the study are to evaluate the prevalence of sBRCAm versus gBRCAm in newly diagnosed ovarian cancer patients and to describe current ovarian cancer counselling and treatment approach patterns at front line setting across Latin America.

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.

Eligibility 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

Primary outcomes:
measure: Prevalence of BRCA 1 and BRCA 2 mutations in newly diagnosed ovarian cancer patients from Latinoamerican population
timeFrame: up to one year
Secondary outcomes:
measure: Prevalence of somatic and germline BRCA 1 and 2 mutations across Latinamerican population
timeFrame: up to one year
measure: Counselling approach in ovarian cancer across Latinamerican countries
timeFrame: up to one year
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Research Site
city: Buenos Aires
country: Argentina
facility: Research Site
city: Caba
country: Argentina
facility: Research Site
city: Cordoba
country: Argentina
facility: Research Site
city: La Rioja
country: Argentina
facility: Research Site
city: Resistencia
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: Barretos
country: Brazil
facility: Research Site
city: Belo Horizonte
country: Brazil
facility: Research Site
city: Curitiba
country: Brazil
facility: Research Site
city: Fortaleza
country: Brazil
facility: Research Site
city: Fortaleza
country: Brazil
facility: Research Site
city: Jaú
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: Salvador
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: São Paulo
country: Brazil
facility: Research Site
city: Bogota
country: Colombia
facility: Research Site
city: Bogotá
country: Colombia
facility: Research Site
city: Cali
country: Colombia
facility: Research Site
city: Medellín
country: Colombia
facility: Research Site
city: México
country: Mexico
facility: Research Site
city: Ciudad de Panama
country: Panama
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: San Isidro
country: Peru
facility: Research Site
Study officials:
References:
citation: 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.