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Radical Fimbriectomy for Young BRCA Mutation Carriers

Study acronym: FIMBRIECTOMIE
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Start date: Dec 2011 to Jan 9, 2012v14
  2. Minor Publications: details revised at 2 of 2 entriesv13
  3. Minor Study Identification, Study Status, Oversight, Referencesv12
  4. Notable Primary completion date: Dec 2019 to Aug 2033
    • Study completion date: Dec 2025 to Aug 2033
    v11
  5. Minor Secondary endpoints: 5 to 8
    • Collaborators revised (2)
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Minor Secondary endpoints: 4 to 5
    • Study sites revised (14)
    • Collaborators expanded, about 4 words
    v9
  2. Minor Re-verified, no change to tracked fieldsv8
  3. Minor Study sites: 22 to 14
    • Primary completion date: Oct 2019 to Dec 2019
    • Study completion date: Oct 2025 to Dec 2025
    v7
  4. Notable Phase: Phase 2 to Not applicable
    • Primary completion date: Oct 2017 to Oct 2019
    • Study completion date: Dec 2027 to Oct 2025
    v6
  5. Notable Primary completion date: Jun 2016 to Oct 2017v5 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 120 to confirmed 123
    • Study completion date: Jun 2019 to Dec 2027
    • Site details revised at 22 of 22 sites
  6. Minor Study sites: 21 to 22v4
  7. Minor Study sites: 11 to 21v3
  8. Minor Study sites: 9 to 11v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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Some BRCA-mutated women are reluctant to undergo laparoscopic bilateral salpingo-oophorectomy. The goal of the bilateral laparoscopic radical fimbriectomy the investigators suggest, is to suppress the tubal source of possible dysplastic cells from which can stem this high grade tumor, while preserving a natural ovarian hormonal secretion.
Trial Details
NCT Number NCT01608074
Lead Sponsor Centre Oscar Lambret
Collaborators: CTD-CNO, Laboratoire PRISM
Conditions
(from sponsor)
BRCA1 Mutation, BRCA2 Mutation, Hereditary Breast and Ovarian Cancer
Related terms Hereditary Breast and Ovarian Cancer Syndrome
Enrollment 123 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov