SDH-Related Familial ParagangliomaPGLEXPO2NCT06408402
Impact of Environmental Exposures on Tumor Risk in SDHx-mutation Carriers
An observational study of SDH-Related Familial Paraganglioma and SDHx-Related Syndromes, run by Assistance Publique - Hôpitaux de Paris at 20 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SDH-Related Familial Paraganglioma, SDHx-Related Syndromes, SDH Gene Mutation
- How many people
- 1,300 participants
- Where
- 20 sitesFrance
- Study dates
- 22 May 2024to 22 May 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- Cases: SDHx mutation carriers diagnosed for a SDHx-related tumor
- Controls: SDHx mutation carriers with no SDHx-related tumor
Who cannot join
- Incapacity to exercise free and informed consent for the study
- Patient under tutorship or guardianship or legal safeguard
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
France20 sites, 1 recruiting
- Active, not recruiting
CHU d'Angers
Angers, 49000
- Active, not recruiting
CHU Jean Minjoz Besançon
Besançon, 25030
- Active, not recruiting
Hôpital Louis Pradel
Bron, 69677
- Active, not recruiting
CHU de Caen
Caen, 14033
- Active, not recruiting
Hôpital Michalon - CHU Grenoble
Grenoble, 38043
- Active, not recruiting
CHU de Lille - Hôpital HURIEZ
Lille, 59037
- Active, not recruiting
Hopital de la Conception - Marseille
Marseille, 13385
- Active, not recruiting
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, 34295
- Active, not recruiting
CHU de Nantes
Nantes, 44093
- Active, not recruiting
CHU de Nice -Hôpital Archet 2
Nice, 06202
- Active, not recruiting
Hôpital Pitié-Salpêtrière - APHP
Paris, 75013
- Active, not recruiting
Hôpital Cochin - APHP
Paris, 75014
- Recruiting
Hôpital européen Georges Pompidou - APHP
Paris, 75015
Anne-Paule GIMENEZ ROQUEPLO, 01 56 09 38 78, anne-paule.gimenez-roqueplo@aphp.fr
- Active, not recruiting
Hôpital européen Georges Pompidou - APHP
Paris, 75015
- Active, not recruiting
CHU de Poitiers
Poitiers, 86021
- Active, not recruiting
CHU de Rennes - Hôpital Sud
Rennes, 35000
- Active, not recruiting
Hôpitaux universitaire de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67098
- Active, not recruiting
CHU de Toulouse - Hôpita Larrey
Toulouse, 31059
- Active, not recruiting
CHU Bretonneau
Tours, 37000
- Active, not recruiting
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: Impact of Environmental Exposures on Tumor Risk in Subjects at Risk of Hereditary SDHx-related Paragangliomas - National Study
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
Read the 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
- Conditions
- SDH-Related Familial Paraganglioma, SDHx-Related Syndromes, SDH Gene Mutation, Environmental Exposure
- Keywords
- hereditary paraganglioma, SDHx gene mutation, environmental exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Cases: SDHx mutation carriers diagnosed for a SDHx-related tumor | |
| Controls | Controls : SDHx mutation carriers with no SDHx-related tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of SDHi exposure in paraganglioma occurence
Association between exposures and tumor occurrence measure with Odd ratio
Measured: 36 months
Secondary outcomes (2)
Spatial distribution of cases
Spatial distribution of tumor incidence
Measured: 48 months
Incidence rate in France of pathologies linked to SDHx gene mutations
Incidence rate in France of pathologies linked to SDHx gene mutations
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start22 May 2024
- Primary completion22 May 2028 (estimated)
- Study completion22 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SDH-Related Familial ParagangliomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, ANSES, Centre Leon Berard
- Responsible party
- Sponsor
- Investigators
- Anne-Paule Gimenez-Roqueplo, MD, PhD, Study director, Hôpital européen Georges Pompidou - APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408402
- Sponsor's protocol ID
- APHP230878
- Other IDs
- HGT/MFI/AR245071, 2023-A02297-38
- Acronym
- PGLEXPO2
- Status last verified
- Jul 2026
- First submitted
- 27 Mar 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared