Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06022016

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

Led by Institut Claudius Regaud · Updated on 2025-12-08

910

Participants Needed

5

Research Sites

319 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Personal history or current diagnosis of blood disorder (hemopathy) for index cases
  • Presence of DDX41 tumor mutation with allelic frequency ≥ 30% confirmed by molecular analysis for index cases
  • Deceased index cases included if DDX41 tumor mutation is accompanied by a second somatic DDX41 mutation
  • Known constitutional carrier of DDX41 mutation confirmed after oncogenetic consultation
  • Agreement to release oncogenetic report results
  • Agreement to provide contact details of relatives for study participation
  • Affiliated to French Social Health Insurance
  • Ability and willingness to give informed consent
  • Related family members aged 18 years or older
  • Family members related to an index case included in the study
  • Agreement to undergo saliva test for constitutional DDX41 mutation
  • Ability and willingness to give informed consent for family members
Not Eligible

You will not qualify if you...

  • No history or current blood disorder for index cases
  • Inability to complete questionnaire for social or psychological reasons
  • Forfeiture of legal freedom or under legal protection (curatorship, guardianship, or protection of justice)
  • Related cases excluded if related in the 4th or 5th degree to an index case (from version 2 of protocol)
  • Person already identified as an index case in the study

AI-Screening

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Trial Site Locations

Total: 5 locations

1

Chu de Bordeaux

Bordeaux, France

Actively Recruiting

2

Chu de Limoges

Limoges, France

Actively Recruiting

3

Institut Paoli-Calmettes

Marseille, France

Actively Recruiting

4

Chu de Montpellier

Montpellier, France

Actively Recruiting

5

IUCT-O

Toulouse, France

Actively Recruiting

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Research Team

P

Pierre VANDE PERRE

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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