- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05014698
IDEntification of New Predisposition Genes in Differentiated THYroid Cancer (IDENTHY-K)
Study Overview
Status
Intervention / Treatment
Detailed Description
The purpose of this research is to find new predisposition genes for differentiated thyroid cancer (DTC). Therefore, in the absence of a BAP1 and DICER1 abnormality, we offer to sequence your whole genome (WGS) or partial genome (genotyping) for a previously unknown genetic abnormality.
Furthermore, the discovery of new genes would be a major medical advance that could contribute to the identification of new therapeutic targets.
This research will be conducted at the University Hospital of Nantes and the Hospital of Vendée and 95 people should participate.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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La Roche-sur-Yon, France
- Vendée Hospital
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Nantes, France, 44093
- Nantes University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Probant subjects
- Minor or adult subject
- Adult subject or legal guardian for minor subjects agreeing to sign the study consent and biospecimen consent
- Subject with differentiated thyroid cancer without an identified causative mutation in the BAP1 and DICER 1 predisposition genes
- Patient affiliated to a valid social security plan
Relative subjects
- Adult subjects
- Subject agreeing to sign the study consent and the biocollection consent
- Subject with differentiated thyroid cancer or from a family with several cases of differentiated thyroid cancer without a causal mutation identified in the BAP1 and DICER 1 predisposition genes
- Patient affiliated to a social security plan
Exclusion Criteria:
- Subject refusing to participate
- Subjects with a causal mutation identified in the predisposition genes: BAP1 and DICER 1
- Subjects under guardianship, curatorship or safeguard of justice or not socially insured
- Subjects with another syndromic predisposition to thyroid cancer (Cowden, Werner, PAF)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: WGS
at inclusion visit : - Blood collection for whole Genome sequencing will be performed At final visit : the results of the WGS will be delivered to patients |
Whole Genome sequencing
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Type and Number of genetic variants associated with or causing the development of differentiated thyroid cancer
Time Frame: within 2 years
|
To be achieved by a whole genome sequencing (WGS) approach in a familial analysis of patients with differentiated thyroid cancer.
In addition, high-throughput genotyping of multiple individuals in each family will allow complementary detection of genomic regions that are shared only by affected subjects
|
within 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of phenotypes associated to genotypes of CDT
Time Frame: within 2 years
|
By studying the association between the clinical characteristics of patients and the identified genetic variants
|
within 2 years
|
|
Analysis of birthplace/family origin information
Time Frame: within 2 years
|
Definition of the spatial location of family forms of CDT and to identify possible founding effects
|
within 2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC19_0414
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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