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New treatment option for DDX41 Gene Mutation
Official title Study of Families With an Hemopathies Predisposition Related to the DDX41 Gene.
ClinicalTrials.gov ID: NCT06022016
What this study is testing
What is For each person (index case or related) included in this study:?
For each person (index case or related) included in this study: is an investigational medicine, being studied as a potential treatment for ddx41 gene mutation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Index cases:
- Women or man aged ≥ 18 years old.
- Personal history(s) of hemopathy or patient with hemopathy at the time of inclusion.
- Patient with a tumor mutation of DDX41 with an allelic frequency (AF) ≥ 30% (with total depth of nucleotide position \>300x: provide tumor molecular...
- Patient (or beneficiary) agreeing to release results of oncogenetic report.
You likely can't join if
- No history of hemopathy or no current hemopathy.
- Patient (or beneficiary) unable to complete questionnaire for social or psychological reasons.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection...
- Women or man aged ≥ 18 years old.
- Related to an index case included in the LUCID study.
- Agreeing to carry out a scientific salivary test for the constitutional research of the DDX41 mutation.
See the full eligibility criteria
- Index cases:
- Women or man aged ≥ 18 years old.
- Personal history(s) of hemopathy or patient with hemopathy at the time of inclusion.
- Patient with a tumor mutation of DDX41 with an allelic frequency (AF) ≥ 30% (with total depth of nucleotide position \>300x: provide tumor molecular analysis report). Special case of inclusion of deceased index cases...
- Patient (or beneficiary) agreeing to release results of oncogenetic report.
- Patient (or beneficiary) agrees to communicate the contact details of his relatives and that they may be contacted by mail to participate in the LUCID study.
- Patient affiliated to a Social Health Insurance in France.
- Patient able to participate and willing to give informed consent prior performance of any study-related procedures.
- No history of hemopathy or no current hemopathy.
- Patient (or beneficiary) unable to complete questionnaire for social or psychological reasons.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice). Related cases (Family member): Inclusion Criteria:
- Women or man aged ≥ 18 years old.
- Related to an index case included in the LUCID study.
- Agreeing to carry out a scientific salivary test for the constitutional research of the DDX41 mutation.
- Patient affiliated to a Social Health Insurance in France.
- Patient able to participate and willing to give informed consent prior performance of any study-related procedures. Exclusion Criteria:
- Not applicable from version 2 of the protocol. Related in the 4th or 5th degree to an index case included in the LUCID study.
- Person already identified as an index case in the LUCID study.
- Person unable to complete questionnaire for social or psychological reasons.
- Person who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Limoges, France
- Marseille, France
- Montpellier, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Limoges, France; Marseille, France; Montpellier, France; Toulouse, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.