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

July 9, 2020 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

471

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1118AAT
        • Research Site
      • Buenos Aires, Argentina, C1431FWO
        • Research Site
      • Caba, Argentina, C1426ANZ
        • Research Site
      • Cordoba, Argentina, 5000
        • Research Site
      • La Rioja, Argentina, 5300
        • Research Site
      • Resistencia, Argentina, 3500
        • Research Site
      • Rosario, Argentina, S2000KZE
        • Research Site
  • Brazil
      • Barretos, Brazil, 14784-400
        • Research Site
      • Belo Horizonte, Brazil, 30130-100
        • Research Site
      • Curitiba, Brazil, 81520-060
        • Research Site
      • Fortaleza, Brazil, 60336-045
        • Research Site
      • Fortaleza, Brazil, 60430-230
        • Research Site
      • Jaú, Brazil, 17210-120
        • Research Site
      • Porto Alegre, Brazil, 90610-000
        • Research Site
      • Rio de Janeiro, Brazil, 22793-080
        • Research Site
      • Rio de Janeiro, Brazil, 20560-120
        • Research Site
      • Salvador, Brazil, 41950-610
        • Research Site
      • Sao Paulo, Brazil, 01246-000
        • Research Site
      • São Paulo, Brazil, 01317-000
        • Research Site
  • Colombia
      • Bogota, Colombia
        • Research Site
      • Bogotá, Colombia
        • Research Site
      • Cali, Colombia
        • Research Site
      • Medellín, Colombia
        • Research Site
  • Mexico
      • México, Mexico, 1400
        • Research Site
  • Panama
      • Ciudad de Panama, Panama
        • Research Site
  • Peru
      • Lima, Peru, LIMA 11
        • Research Site
      • Lima, Peru, 0051
        • Research Site
      • San Isidro, Peru
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of somatic and germline BRCA 1 and 2 mutations across Latinamerican population
Time Frame: up to one year
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
up to one year
Counselling approach in ovarian cancer across Latinamerican countries
Time Frame: up to one year
To describe all professionals participating in this process, and time for the approach
up to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2016

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

December 2, 2016

First Posted (Estimate)

December 7, 2016

Study Record Updates

Last Update Posted (Actual)

July 10, 2020

Last Update Submitted That Met QC Criteria

July 9, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D0817R00002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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