Impact of Environmental Exposures on Tumor Risk in SDHx-mutation Carriers

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06408402
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Assistance Publique - Hôpitaux de Paris
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Anne-Paule Gimenez-Roqueplo, MD, PhD
Principal Investigator Affiliation Hôpital européen Georges Pompidou - APHP
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

SDH-Related Familial Paraganglioma, SDHx-Related Syndromes, SDH Gene Mutation, Environmental Exposure
Additional Details

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

Arms & Interventions

Arms

: Cases

Cases: SDHx mutation carriers diagnosed for a SDHx-related tumor

: Controls

Controls : SDHx mutation carriers with no SDHx-related tumor

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU d'Angers, Angers, France

Status

Address

CHU d'Angers

Angers, , 49000

Site Contact

Sandrine LABOUREAU

[email protected]

02 41 35 45 93

CHU Jean Minjoz Besançon, Besançon, France

Status

Address

CHU Jean Minjoz Besançon

Besançon, , 25030

Site Contact

Franck SCHILLO

[email protected]

03 81 66 82 29

Hôpital Louis Pradel, Bron, France

Status

Address

Hôpital Louis Pradel

Bron, , 69677

Site Contact

Hélène LASOLLE

[email protected]

04 27 85 66 66

CHU de Caen, Caen, France

Status

Address

CHU de Caen

Caen, , 14033

Site Contact

Julia MORERA

[email protected]

02 31 06 51 85

Hôpital Michalon - CHU Grenoble, Grenoble, France

Status

Address

Hôpital Michalon - CHU Grenoble

Grenoble, , 38043

Site Contact

Justine CRISTANTE

[email protected]

04 76 76 55 09

CHU de Lille - Hôpital HURIEZ, Lille, France

Status

Address

CHU de Lille - Hôpital HURIEZ

Lille, , 59037

Site Contact

Catherine CARDOT BAUTERS

[email protected]

03 20 44 43 34

Hopital de la Conception - Marseille, Marseille, France

Status

Address

Hopital de la Conception - Marseille

Marseille, , 13385

Site Contact

Frederic CASTINETTI

[email protected]

04 91 38 34 79

CHU de Montpellier - Hôpital Lapeyronie, Montpellier, France

Status

Address

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, , 34295

Site Contact

Isabelle RAINGEARD

[email protected]

04 67 33 83 82

CHU de Nantes, Nantes, France

Status

Address

CHU de Nantes

Nantes, , 44093

Site Contact

Delphine DRUI

[email protected]

02 59 48 27 26

CHU de Nice -Hôpital Archet 2, Nice, France

Status

Address

CHU de Nice -Hôpital Archet 2

Nice, , 06202

Site Contact

Nicolas Sébastien CHEVALIER

[email protected]

04 92 03 96 57

Hôpital Pitié-Salpêtrière - APHP, Paris, France

Status

Address

Hôpital Pitié-Salpêtrière - APHP

Paris, , 75013

Site Contact

Charlotte LUSSEY

[email protected]

01 42 17 62 81

Hôpital Cochin - APHP, Paris, France

Status

Address

Hôpital Cochin - APHP

Paris, , 75014

Site Contact

Rossella LIBE

[email protected]

01 58 41 32 49

Hôpital européen Georges Pompidou - APHP, Paris, France

Status

Address

Hôpital européen Georges Pompidou - APHP

Paris, , 75015

Site Contact

Anne-Paule GIMENEZ ROQUEPLO

[email protected]

01 56 09 38 78

Hôpital européen Georges Pompidou - APHP, Paris, France

Status

Address

Hôpital européen Georges Pompidou - APHP

Paris, , 75015

Site Contact

Laurence AMAR

[email protected]

01 56 09 37 71

CHU de Poitiers, Poitiers, France

Status

Address

CHU de Poitiers

Poitiers, , 86021

Site Contact

Aurélie MOIT

[email protected]

05 49 44 40 34

CHU de Rennes - Hôpital Sud, Rennes, France

Status

Address

CHU de Rennes - Hôpital Sud

Rennes, , 35000

Site Contact

Benjamin MOREAU

[email protected]

02 99 26 71 43

Strasbourg, France

Status

Address

Hôpitaux universitaire de Strasbourg - Hôpital de Hautepierre

Strasbourg, , 67098

Site Contact

Bernard GOICHOT

[email protected]

03 88 12 75 94

CHU de Toulouse - Hôpita Larrey, Toulouse, France

Status

Address

CHU de Toulouse - Hôpita Larrey

Toulouse, , 31059

Site Contact

Solange GRUNENWALD

[email protected]

05 67 77 17 01

CHU Bretonneau, Tours, France

Status

Address

CHU Bretonneau

Tours, , 37000

Site Contact

Peggy PIERRE

[email protected]

02 47 47 98 20

Institut Gustave Roussy, Villejuif, France

Status

Address

Institut Gustave Roussy

Villejuif, , 94805

Site Contact

Sophie MOOG

[email protected]

01 42 11 24 07

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