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IDEntification of New Predisposition Genes in Differentiated THYroid Cancer (IDENTHY-K)

Primary Purpose

Differentiated Thyroid Cancer, Thyroid Cancer, Nonmedullary

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
WGS
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Differentiated Thyroid Cancer

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Vendée HospitalRecruiting
  • Nantes University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WGS

Arm Description

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

Outcomes

Primary Outcome Measures

Type and Number of genetic variants associated with or causing the development of differentiated thyroid cancer
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

Secondary Outcome Measures

Number of phenotypes associated to genotypes of CDT
By studying the association between the clinical characteristics of patients and the identified genetic variants
Analysis of birthplace/family origin information
Definition of the spatial location of family forms of CDT and to identify possible founding effects

Full Information

First Posted
August 5, 2021
Last Updated
December 19, 2022
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05014698
Brief Title
IDEntification of New Predisposition Genes in Differentiated THYroid Cancer
Acronym
IDENTHY-K
Official Title
IDEntification of New Predisposition Genes in Differentiated THYroid Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research is to find new predisposition genes for differentiated thyroid cancer (DTC).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Differentiated Thyroid Cancer, Thyroid Cancer, Nonmedullary

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
95 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WGS
Arm Type
Experimental
Arm Description
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
Intervention Type
Genetic
Intervention Name(s)
WGS
Intervention Description
Whole Genome sequencing
Primary Outcome Measure Information:
Title
Type and Number of genetic variants associated with or causing the development of differentiated thyroid cancer
Description
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
Time Frame
within 2 years
Secondary Outcome Measure Information:
Title
Number of phenotypes associated to genotypes of CDT
Description
By studying the association between the clinical characteristics of patients and the identified genetic variants
Time Frame
within 2 years
Title
Analysis of birthplace/family origin information
Description
Definition of the spatial location of family forms of CDT and to identify possible founding effects
Time Frame
within 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Vendée Hospital
City
La Roche-sur-Yon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernardette LUCAS-POULIQUEN, MD
Phone
02 51 44 61 61
Email
bernadette.lucas-pouliquen@ght85.fr
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delphine DRUI, MD
Phone
0240083333
Email
delphine.drui@chu-nantes.fr
First Name & Middle Initial & Last Name & Degree
Delphine DRUI
Email
delphine.drui@chu-nantes.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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IDEntification of New Predisposition Genes in Differentiated THYroid Cancer

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