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Study of Families With an Hemopathies Predisposition Related to the DDX41 Gene.

Study acronym: LUCID
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria shortened, about 19 wordsv9
  2. Primary and study completion dates: Dec 2029 to Jan 2030v8
  3. Re-verified, no change to tracked fieldsv7
  4. Site details revised at 2 of 5 sitesv6
  5. Site details revised at 2 of 5 sitesv5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date changed from estimate of Dec 2023 to Nov 17, 2023v4
  2. Start date: Oct 2023 to Dec 2023v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Nov 2029 to Dec 2029
    • Start date: Sep 2023 to Oct 2023
    • Site details revised at 5 of 5 sites
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a multicenter, interventional, historico-prospective cohort pilot study aimed at specifying the phenotype of subjects carrying a constitutional familial DDX41 mutation, with a view to eventually publishing oncogenetic recommendations for carriers of this mutation. The main objective of the LUCID project is to assess the cumulative risk of hematological diseases as a function of age in DDX41 germline mutation carriers. This study will be carried out in two stages: Stage 1: Inclusion of index cases in an oncogenetic consultation (salivary test, completion of an health self-questionnaire and collection of contact details for the related cases). Stage 2: Proposition of participation to family members, by correspondence, and determination of carrier or non-carrier status of the constitutional familial DDX41 mutation (based on a salivary test). A maximum of 210 index case patients and 700 family member will be included in this study.
Trial Details
NCT Number NCT06022016
Lead Sponsor Institut Claudius Regaud
Conditions
(from sponsor)		 DDX41 Gene Mutation
Related terms Leukemia, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
Enrollment 910 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov