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

NCT ID: NCT06408402

Last Updated: 2024-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2028-05-01

Brief Summary

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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

Detailed Description

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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

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SDH-Related Familial Paraganglioma SDHx-Related Syndromes SDH Gene Mutation Environmental Exposure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cases

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

No interventions assigned to this group

Controls

Controls : SDHx mutation carriers with no SDHx-related tumor

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

ANSES

OTHER

Sponsor Role collaborator

Centre Leon Berard

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne-Paule Gimenez-Roqueplo, MD, PhD

Role: STUDY_DIRECTOR

Hôpital européen Georges Pompidou - APHP

Locations

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CHU d'Angers

Angers, , France

Site Status

CHU Jean Minjoz Besançon

Besançon, , France

Site Status

Hôpital Louis Pradel

Bron, , France

Site Status

CHU de Caen

Caen, , France

Site Status

Hôpital Michalon - CHU Grenoble

Grenoble, , France

Site Status

CHU de Lille - Hôpital HURIEZ

Lille, , France

Site Status

Hopital de la Conception - Marseille

Marseille, , France

Site Status

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, , France

Site Status

CHU de Nantes

Nantes, , France

Site Status

CHU de Nice -Hôpital Archet 2

Nice, , France

Site Status

Hôpital Pitié-Salpêtrière - APHP

Paris, , France

Site Status

Hôpital Cochin - APHP

Paris, , France

Site Status

Hôpital européen Georges Pompidou - APHP

Paris, , France

Site Status

Hôpital européen Georges Pompidou - APHP

Paris, , France

Site Status

CHU de Poitiers

Poitiers, , France

Site Status

CHU de Rennes - Hôpital Sud

Rennes, , France

Site Status

Hôpitaux universitaire de Strasbourg - Hôpital de Hautepierre

Strasbourg, , France

Site Status

CHU de Toulouse - Hôpita Larrey

Toulouse, , France

Site Status

CHU Bretonneau

Tours, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

Central Contacts

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Alexandre Buffet, MD, PhD

Role: CONTACT

33-1-56093879

Anne-Paule Gimenez-Roqueplo, MD, PhD

Role: CONTACT

33-1-56093881

Facility Contacts

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Sandrine LABOUREAU

Role: primary

02 41 35 45 93

Franck SCHILLO

Role: primary

03 81 66 82 29

Hélène LASOLLE

Role: primary

04 27 85 66 66

Julia MORERA

Role: primary

02 31 06 51 85

Justine CRISTANTE

Role: primary

04 76 76 55 09

Catherine CARDOT BAUTERS

Role: primary

03 20 44 43 34

Frederic CASTINETTI

Role: primary

04 91 38 34 79

Isabelle RAINGEARD

Role: primary

04 67 33 83 82

Delphine DRUI

Role: primary

02 59 48 27 26

Nicolas Sébastien CHEVALIER

Role: primary

04 92 03 96 57

Charlotte LUSSEY

Role: primary

01 42 17 62 81

Rossella LIBE

Role: primary

01 58 41 32 49

Anne-Paule GIMENEZ ROQUEPLO

Role: primary

01 56 09 38 78

Laurence AMAR

Role: primary

01 56 09 37 71

Aurélie MOIT

Role: primary

05 49 44 40 34

Benjamin MOREAU

Role: primary

02 99 26 71 43

Bernard GOICHOT

Role: primary

03 88 12 75 94

Solange GRUNENWALD

Role: primary

05 67 77 17 01

Peggy PIERRE

Role: primary

02 47 47 98 20

Sophie MOOG

Role: primary

01 42 11 24 07

Other Identifiers

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HGT/MFI/AR245071

Identifier Type: OTHER

Identifier Source: secondary_id

2023-A02297-38

Identifier Type: OTHER

Identifier Source: secondary_id

APHP230878

Identifier Type: -

Identifier Source: org_study_id

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