NCT06408402 Impact of Environmental Exposures on Tumor Risk in SDHx-mutation Carriers
| NCT ID | NCT06408402 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | SDH-Related Familial Paraganglioma |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,300 participants |
| Start Date | 2024-05-22 |
| Primary Completion | 2028-05-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,300 participants in total. It began in 2024-05-22 with a primary completion date of 2028-05-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Anne-Paule Gimenez-Roqueplo, MD, PhD
STUDY DIRECTOR
Hôpital européen Georges Pompidou - APHP
Frequently Asked Questions
Who can join the NCT06408402 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying SDH-Related Familial Paraganglioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06408402 currently recruiting?
Yes, NCT06408402 is actively recruiting participants. Contact the research team at alexandre.buffet@aphp.fr for enrollment information.
Where is the NCT06408402 trial being conducted?
This trial is being conducted at Angers, France, Besançon, France, Bron, France, Caen, France and 11 additional locations.
Who is sponsoring the NCT06408402 clinical trial?
NCT06408402 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Anne-Paule Gimenez-Roqueplo, MD, PhD at Hôpital européen Georges Pompidou - APHP. The trial plans to enroll 1,300 participants.