Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408402
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-03-27
Brief Title:
Impact of Environmental Exposures on Tumor Risk in SDHx-mutation Carriers
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Impact of Environmental Exposures on Tumor Risk in Subjects at Risk of Hereditary SDHx-related Paragangliomas - National Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PGLEXPO2
Brief Summary:
The primary objective of the PGLEXPO-2 study is to test the hypothesis that exposure occupational environmental andor domestic to succinate dehydrogenase inhibitors SDHi could contribute to tumor emergence in subjects carrying a germline mutation in one of the SDHx genesThe 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
In addition a blood sample 10 ml on EDTA will be proposed to the participants to the study
Detailed 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
In addition a blood sample 10 ml on EDTA will be proposed to the participants to the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A02297-38 | OTHER | Agence Nationale de sécurité du médicament et des produits de santé | None |
| HGTMFIAR245071 | OTHER | None | None |