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NCT06408402 Clinical Trial

Impact of Environmental Exposures on Tumor Risk in SDHx-mutation Carriers

Environmental Exposure Clinical Trial

— PGLEXPO2  

Official title:
Impact of Environmental Exposures on Tumor Risk in Subjects at Risk of Hereditary SDHx-related Paragangliomas - National Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06408402
Other study ID # APHP230878
Secondary ID HGT/MFI/AR245071
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2024
Est. completion date May 1, 2028

Study information
Verified date April 2024
Source Assistance Publique - Hôpitaux de Paris
Contact Alexandre Buffet, MD, PhD
Phone 33-1-56093879
Email alexandre.buffet@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective of the PGL.EXPO-2 study is to test the hypothesis that exposure (occupational, environmental and/or domestic) to succinate dehydrogenase inhibitors (SDHi) could contribute to tumor emergence in subjects carrying a germline mutation in one of the SDHx genes.The primary endpoint will be the proportion of subjects (cases or controls) exposed to SDHi and the association with paraganglioma risk. In addition, a blood sample (10 ml on EDTA) will be proposed to the participants to the study

Description:

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 age and type of gene affected. Past exposures will be sought through a telephone questionnaire. In addition, a blood sample (10 ml on EDTA) will be proposed to the participants to the study

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1300
Est. completion date May 1, 2028
Est. primary completion date May 1, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Cases: SDHx mutation carriers diagnosed for a SDHx-related tumor - Controls: SDHx mutation carriers with no SDHx-related tumor Exclusion Criteria: - Incapacity to exercise free and informed consent for the study - Patient under tutorship or guardianship or legal safeguard

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHU d'Angers Angers
France CHU Jean Minjoz Besançon Besançon
France Hôpital Louis Pradel Bron
France CHU de Caen Caen
France Hôpital Michalon - CHU Grenoble Grenoble
France CHU de Lille - Hôpital HURIEZ Lille
France Hopital de la Conception - Marseille Marseille
France CHU de Montpellier - Hôpital Lapeyronie Montpellier
France CHU de Nantes Nantes
France CHU de Nice -Hôpital Archet 2 Nice
France Hôpital Cochin - APHP Paris
France Hôpital européen Georges Pompidou - APHP Paris
France Hôpital européen Georges Pompidou - APHP Paris
France Hôpital Pitié-Salpêtrière - APHP Paris
France CHU de Poitiers Poitiers
France CHU de Rennes - Hôpital Sud Rennes
France Hôpitaux universitaire de Strasbourg - Hôpital de Hautepierre Strasbourg
France CHU de Toulouse - Hôpita Larrey Toulouse
France CHU Bretonneau Tours
France Institut Gustave Roussy Villejuif

Sponsors (4)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris ANSES, Centre Leon Berard, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Impact of SDHi exposure in paraganglioma occurence Association between exposures and tumor occurrence measure with Odd ratio 36 months
Secondary Spatial distribution of cases Spatial distribution of tumor incidence 48 months
Secondary Incidence rate in France of pathologies linked to SDHx gene mutations Incidence rate in France of pathologies linked to SDHx gene mutations 48 months
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