NCT04139096

Brief Summary

Case control on thyroid cancer occuring in a cohort of 7300 subjects treated during their childhood, mostly by radiotherapy, for a skin Angioma at Gustave Roussy, Villejuif France between 1947 and 1973. This case control study, which is included in a larger european project, aims to investigate the DNA variant interacting with the risk of radiation induced thyroid cancer after irradiation. The sutdy is planed to include about 30 cases and 30 controls. Matching criteria are date of birth, gender, and age at irradiation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2019

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2021

Completed
Last Updated

January 23, 2025

Status Verified

January 1, 2025

Enrollment Period

2 years

First QC Date

October 9, 2019

Last Update Submit

January 21, 2025

Conditions

Thyroid NeoplasmsGenetic SusceptibilityRadiation Exposure

Outcome Measures

Primary Outcomes (1)

  • Number of Differentiated thyroid carcinoma

    Number of differentiated thyroid carcinoma occuring in a cohort of subjects treated for a skin hemangioma during the follow-up

    From hemangioma diagnosis to the end of the followup, in average 45 years after hemangioma diagnosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cohort of subjects treated for a skin hemangioma at Gustave Roussy Institute from 1947 to 1973, mostly by radiotherapy.

You may qualify if:

  • Diganosis of thyroid cancer during the followup or selected as a control matched on gender, date of birth and age at skin hemangioma diagnosis.

You may not qualify if:

  • No available adress Refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gustae Roussy

Villejuif, Val de Marne, 948000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples

MeSH Terms

Conditions

Thyroid NeoplasmsGenetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesDisease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Florent de Vathaire, PhD

    Institut National de la Santé Et de la Recherche Médicale, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2019

First Posted

October 25, 2019

Study Start

September 22, 2019

Primary Completion

September 22, 2021

Study Completion

September 22, 2021

Last Updated

January 23, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)