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| ID | Type | Description | Link |
|---|---|---|---|
| HGT/MFI/AR245071 | Other Identifier | Commission Nationale de l'Informatique et des Libertés | |
| 2023-A02297-38 | Other Identifier | Agence Nationale de sécurité du médicament et des produits de santé |
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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| ANSES | OTHER |
| Centre Leon Berard | OTHER |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | Cases: SDHx mutation carriers diagnosed for a SDHx-related tumor | ||
| Controls | Controls : SDHx mutation carriers with no SDHx-related tumor |
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| Measure | Description | Time Frame |
|---|---|---|
| Impact of SDHi exposure in paraganglioma occurence | Association between exposures and tumor occurrence measure with Odd ratio | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Spatial distribution of cases | Spatial distribution of tumor incidence | 48 months |
| Incidence rate in France of pathologies linked to SDHx gene mutations | Incidence rate in France of pathologies linked to SDHx gene mutations |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandre Buffet, MD, PhD | Contact | 33-1-56093879 | alexandre.buffet@aphp.fr | |
| Anne-Paule Gimenez-Roqueplo, MD, PhD | Contact | 33-1-56093881 | anne-paule.gimenez-roqueplo@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Anne-Paule Gimenez-Roqueplo, MD, PhD | Hôpital européen Georges Pompidou - APHP | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Angers | Active, not recruiting | Angers | 49000 | France | ||
| CHU Jean Minjoz Besançon |
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Two years after the last publication
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).
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A blood sample (10 ml on EDTA) will be proposed to the participants to the study
| 48 months |
| Active, not recruiting |
| Besançon |
| 25030 |
| France |
| Hôpital Louis Pradel | Active, not recruiting | Bron | 69677 | France |
| CHU de Caen | Active, not recruiting | Caen | 14033 | France |
| Hôpital Michalon - CHU Grenoble | Active, not recruiting | Grenoble | 38043 | France |
| CHU de Lille - Hôpital HURIEZ | Active, not recruiting | Lille | 59037 | France |
| Hopital de la Conception - Marseille | Active, not recruiting | Marseille | 13385 | France |
| CHU de Montpellier - Hôpital Lapeyronie | Active, not recruiting | Montpellier | 34295 | France |
| CHU de Nantes | Active, not recruiting | Nantes | 44093 | France |
| CHU de Nice -Hôpital Archet 2 | Active, not recruiting | Nice | 06202 | France |
| Hôpital Pitié-Salpêtrière - APHP | Active, not recruiting | Paris | 75013 | France |
| Hôpital Cochin - APHP | Active, not recruiting | Paris | 75014 | France |
| Hôpital européen Georges Pompidou - APHP | Recruiting | Paris | 75015 | France |
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| Hôpital européen Georges Pompidou - APHP | Active, not recruiting | Paris | 75015 | France |
| CHU de Poitiers | Active, not recruiting | Poitiers | 86021 | France |
| CHU de Rennes - Hôpital Sud | Active, not recruiting | Rennes | 35000 | France |
| Hôpitaux universitaire de Strasbourg - Hôpital de Hautepierre | Active, not recruiting | Strasbourg | 67098 | France |
| CHU de Toulouse - Hôpita Larrey | Active, not recruiting | Toulouse | 31059 | France |
| CHU Bretonneau | Active, not recruiting | Tours | 37000 | France |
| Institut Gustave Roussy | Active, not recruiting | Villejuif | 94805 | France |