NCT02984423

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
471

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Typical duration for all trials

Geographic Reach
6 countries

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
20 days until next milestone

Study Start

First participant enrolled

December 27, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

July 10, 2020

Status Verified

July 1, 2020

Enrollment Period

2.5 years

First QC Date

November 23, 2016

Last Update Submit

July 9, 2020

Conditions

Ovarian Cancer

Keywords

Ovarian CancerBRCA mutations

Outcome Measures

Primary Outcomes (1)

  • Prevalence of BRCA 1 and BRCA 2 mutations in newly diagnosed ovarian cancer patients from Latinoamerican population

    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 Outcomes (2)

  • Prevalence of somatic and germline BRCA 1 and 2 mutations across Latinamerican population

    up to one year

  • Counselling approach in ovarian cancer across Latinamerican countries

    up to one year

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Newly diagnosed patients with (FIGO) stage III or IV ovarian epithelial, primary peritoneal, or fallopian tube cancer made

You may not qualify if:

  • 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
  • Be a patient who, in the judgement of the Investigator, would be inappropriate for enrollment in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Research Site

Buenos Aires, C1118AAT, Argentina

Location

Research Site

Buenos Aires, C1431FWO, Argentina

Location

Research Site

CABA, C1426ANZ, Argentina

Location

Research Site

Córdoba, 5000, Argentina

Location

Research Site

La Rioja, 5300, Argentina

Location

Research Site

Resistencia, 3500, Argentina

Location

Research Site

Rosario, S2000KZE, Argentina

Location

Research Site

Barretos, 14784-400, Brazil

Location

Research Site

Belo Horizonte, 30130-100, Brazil

Location

Research Site

Curitiba, 81520-060, Brazil

Location

Research Site

Fortaleza, 60336-045, Brazil

Location

Research Site

Fortaleza, 60430-230, Brazil

Location

Research Site

Jaú, 17210-120, Brazil

Location

Research Site

Porto Alegre, 90610-000, Brazil

Location

Research Site

Rio de Janeiro, 20560-120, Brazil

Location

Research Site

Rio de Janeiro, 22793-080, Brazil

Location

Research Site

Salvador, 41950-610, Brazil

Location

Research Site

São Paulo, 01246-000, Brazil

Location

Research Site

São Paulo, 01317-000, Brazil

Location

Research Site

Bogotá, Colombia

Location

Research Site

Cali, Colombia

Location

Research Site

Medellín, Colombia

Location

Research Site

México, 1400, Mexico

Location

Research Site

Panama City, Panama

Location

Research Site

Lima, 0051, Peru

Location

Research Site

Lima, LIMA 11, Peru

Location

Research Site

San Isidro, Peru

Location

Related Publications (1)

  • 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.

    PMID: 33415992DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2016

First Posted

December 7, 2016

Study Start

December 27, 2016

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

July 10, 2020

Record last verified: 2020-07

Locations

PA(1)PE(3)AR(7)CO(3)ME(1)BR(12)