Impact of Environmental Exposures on Tumor Risk in SDHx-mutation Carriers
PGLEXPO2
3 other identifiers
observational
1,300
1 country
20
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2024
Longer than P75 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2024
CompletedFirst Posted
Study publicly available on registry
May 10, 2024
CompletedStudy Start
First participant enrolled
May 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 22, 2028
July 9, 2026
July 1, 2026
4 years
March 27, 2024
July 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Impact of SDHi exposure in paraganglioma occurence
Association between exposures and tumor occurrence measure with Odd ratio
36 months
Secondary Outcomes (2)
Spatial distribution of cases
48 months
Incidence rate in France of pathologies linked to SDHx gene mutations
48 months
Study Arms (2)
Cases
Cases: SDHx mutation carriers diagnosed for a SDHx-related tumor
Controls
Controls : SDHx mutation carriers with no SDHx-related tumor
Eligibility Criteria
650 cases and 650 controls will be enrolled in different French referral centers where they are regularly managed and followed for a SDHx-related tumor risk. They will be matched on their date of birth
You may qualify if:
- Cases: SDHx mutation carriers diagnosed for a SDHx-related tumor
- Controls: SDHx mutation carriers with no SDHx-related tumor
You may not qualify if:
- Incapacity to exercise free and informed consent for the study
- Patient under tutorship or guardianship or legal safeguard
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut National de la Santé Et de la Recherche Médicale, Francecollaborator
- ANSEScollaborator
- Centre Leon Berardcollaborator
- Assistance Publique - Hôpitaux de Parislead
Study Sites (20)
CHU d'Angers
Angers, 49000, France
CHU Jean Minjoz Besançon
Besançon, 25030, France
Hôpital Louis Pradel
Bron, 69677, France
CHU de Caen
Caen, 14033, France
Hôpital Michalon - CHU Grenoble
Grenoble, 38043, France
CHU de Lille - Hôpital HURIEZ
Lille, 59037, France
Hopital de la Conception - Marseille
Marseille, 13385, France
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, 34295, France
CHU de Nantes
Nantes, 44093, France
CHU de Nice -Hôpital Archet 2
Nice, 06202, France
Hôpital Pitié-Salpêtrière - APHP
Paris, 75013, France
Hôpital Cochin - APHP
Paris, 75014, France
Hôpital européen Georges Pompidou - APHP
Paris, 75015, France
Hôpital européen Georges Pompidou - APHP
Paris, 75015, France
CHU de Poitiers
Poitiers, 86021, France
CHU de Rennes - Hôpital Sud
Rennes, 35000, France
Hôpitaux universitaire de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67098, France
CHU de Toulouse - Hôpita Larrey
Toulouse, 31059, France
CHU Bretonneau
Tours, 37000, France
Institut Gustave Roussy
Villejuif, 94805, France
Biospecimen
A blood sample (10 ml on EDTA) will be proposed to the participants to the study
Study Officials
- STUDY DIRECTOR
Anne-Paule Gimenez-Roqueplo, MD, PhD
Hôpital européen Georges Pompidou - APHP
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2024
First Posted
May 10, 2024
Study Start
May 22, 2024
Primary Completion (Estimated)
May 22, 2028
Study Completion (Estimated)
May 22, 2028
Last Updated
July 9, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Two years after the last publication
- Access Criteria
- Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared