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NCT04481152 Clinical Trial

Impact of Environmental Exposures on Tumor Risk in Subjects at Risk of Hereditary SDHx Paraganglioma

Genetic Predisposition Clinical Trial

— PGL-EXPO-1  

Official title:
Impact of Environmental Exposures on Tumor Risk in Subjects at Risk of Hereditary SDHx-related Paragangliomas, Pilot Phase

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04481152
Other study ID # APHP191007
Secondary ID 2020-A00567-32
Status Not yet recruiting
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date September 1, 2022

Study information
Verified date January 2022
Source Assistance Publique - Hôpitaux de Paris
Contact Anne-Paule GIMENEZ-ROQUEPLO, MD, PhD
Phone 33 1 56 09 38 81
Email anne-paule.gimenez-roqueplo@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main objective of the pilot phase of PGLEXPO will be to assess the faisability and to precise methodology of a case-control study designed for testing the impact of environmental and professional exposures on the tumoral risk in SDHx-mutation carriers

Description:

The main objective of the pilot phase of PGLEXPO will be to assess the faisability and to precise methodology of a case-control study designed for testing the impact of environmental and professional exposures on the tumoral risk in SDHx-mutation carriers. Patients will be selected from subjects with a mutation in one of the SDHx genes. The cases will have developed a tumor, while the controls will be tumor-free. Controls will be matched to the cases according to sex, age and type of gene affected. Past exposures will be sought through a telephone questionnaire.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date September 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Cases: SDHx mutation carriers diagnosed for a SDHx-related tumor 2. Controls: SDHx mutation carriers with no SDHx-related tumor Exclusion Criteria: Incapacity to exercise free and informed consent for the study

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris ANSES, Institut National de la Santé Et de la Recherche Médicale, France

Outcome
Type Measure Description Time frame Safety issue
Primary Feasability of the protocol of a national case/control study (PGL.EXPO2) Successful pairing of 50 cases with 50 controls 2 years
Secondary Feasibility of matching cases and controls Proportion of cases for which a control could be identified 2 years
Secondary Ease of matching cases and controls Mean number of controls matching for a case 2 years
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