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Recruiting

NCT Number: NCT03667417

Genetic Predisposition to Breast and Ovarian Cancer: Prospective Study of BRCAx Gene Mutation

Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers

Recruiting

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Key information

Conditions

Breast Cancers Adnexal Diseases Breast Diseases Breast Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Cancers Ovarian Diseases Ovarian Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Paoli-Calmettes

Marseille, 13009, France

Location status: Recruiting

Location contact

Catherine NOGUES, MD

CONTACT

[email protected]

334 91 223395

Catherine NOGUES, MD

PRINCIPAL_INVESTIGATOR

About this study

Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • Woman or man, with or without cancer, carrying a deleterious BRCA1/BRCA2 mutation, aged 18 years and over.
  • Woman with or without breast cancer or ovarian cancer at baseline.
  • Man with or without breast cancer at baseline.
  • Signed consent to participation
  • Affiliation to a social security regimen, or beneficiary of such a regimen.

Exclusion criteria

  • A person of legal age subject to a legal protection measure, or unable to express consent.
  • Impossibility to submit to the follow-up of the test for geographical, social or psychological reasons

Treatment and study plan

questionnaires

Other

standardized data collection and 10-year prospective follow-up

Primary outcomes

  1. Incidence of breast and / or ovarian cancer during subject lifetime

    Time frame: 10 years

    risk that a subject with a mutation develops breast and / or ovarian cancer during his lifetime, assessed by epidemiologic questionnaires (carcinologic events).

Study contacts

Contact information is provided by the study sponsor or research team.

Dominique GENRE, MD

CONTACT

[email protected]

33 491 22 37 78

Margot BERLINE, MSc, MBA

CONTACT

[email protected]

33 491 22 33 14

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Collaborators

  • UNICANCER - Le Groupe génétique et cancer (GGC)

Registry information

Acronym: GENEPSO

Important dates

Study start
1999
Primary completion
2028
Study completion
2028
First posted
Sep 12, 2018
Registry last updated
Jul 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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