Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06022016
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2023-08-28
Brief Title:
Study of Families With an Hemopathies Predisposition Related to the DDX41 Gene
Sponsor:
Institut Claudius Regaud
Organization:
Institut Claudius Regaud
Study Overview
Official Title:
Study of Families With an Hemopathies Predisposition Related to the DDX41 Gene
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LUCID
Brief Summary:
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 Myelodysplastic syndromeacute myeloid leukemia MDSAML or cytopenia 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
The main objective of the LUCID project is to assess the cumulative risk of hematological diseases Myelodysplastic syndromeacute myeloid leukemia MDSAML or cytopenia 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None