Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT06408402
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Environmental Exposures on Tumor Risk in SDHx-mutation Carriers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'A blood sample (10 ml on EDTA) will be proposed to the participants to the study'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2028-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2024-03-27', 'studyFirstSubmitQcDate': '2024-05-06', 'lastUpdatePostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of SDHi exposure in paraganglioma occurence', 'timeFrame': '36 months', 'description': 'Association between exposures and tumor occurrence measure with Odd ratio'}], 'secondaryOutcomes': [{'measure': 'Spatial distribution of cases', 'timeFrame': '48 months', 'description': 'Spatial distribution of tumor incidence'}, {'measure': 'Incidence rate in France of pathologies linked to SDHx gene mutations', 'timeFrame': '48 months', 'description': 'Incidence rate in France of pathologies linked to SDHx gene mutations'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hereditary paraganglioma', 'SDHx gene mutation', 'environmental exposure'], 'conditions': ['SDH-Related Familial Paraganglioma', 'SDHx-Related Syndromes', 'SDH Gene Mutation', 'Environmental Exposure']}, 'descriptionModule': {'briefSummary': '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.\n\nIn addition, a blood sample (10 ml on EDTA) will be proposed to the participants to the study', 'detailedDescription': '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.\n\nIn addition, a blood sample (10 ml on EDTA) will be proposed to the participants to the study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cases: SDHx mutation carriers diagnosed for a SDHx-related tumor\n* Controls: SDHx mutation carriers with no SDHx-related tumor\n\nExclusion Criteria:\n\n* Incapacity to exercise free and informed consent for the study\n* Patient under tutorship or guardianship or legal safeguard'}, 'identificationModule': {'nctId': 'NCT06408402', 'acronym': 'PGLEXPO2', 'briefTitle': 'Impact of Environmental Exposures on Tumor Risk in SDHx-mutation Carriers', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Impact of Environmental Exposures on Tumor Risk in Subjects at Risk of Hereditary SDHx-related Paragangliomas - National Study', 'orgStudyIdInfo': {'id': 'APHP230878'}, 'secondaryIdInfos': [{'id': 'HGT/MFI/AR245071', 'type': 'OTHER', 'domain': "Commission Nationale de l'Informatique et des Libertés"}, {'id': '2023-A02297-38', 'type': 'OTHER', 'domain': 'Agence Nationale de sécurité du médicament et des produits de santé'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Cases: SDHx mutation carriers diagnosed for a SDHx-related tumor'}, {'label': 'Controls', 'description': 'Controls : SDHx mutation carriers with no SDHx-related tumor'}]}, 'contactsLocationsModule': {'locations': [{'zip': '49000', 'city': 'Angers', 'country': 'France', 'contacts': [{'name': 'Sandrine LABOUREAU', 'role': 'CONTACT', 'email': 'salaboureau@chu-angers.fr', 'phone': '02 41 35 45 93'}], 'facility': "CHU d'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'contacts': [{'name': 'Franck SCHILLO', 'role': 'CONTACT', 'email': 'fschillo@chu-besancon.fr', 'phone': '03 81 66 82 29'}], 'facility': 'CHU Jean Minjoz Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '69677', 'city': 'Bron', 'country': 'France', 'contacts': [{'name': 'Hélène LASOLLE', 'role': 'CONTACT', 'email': 'helene.lasolle@chu-lyon.fr', 'phone': '04 27 85 66 66'}], 'facility': 'Hôpital Louis Pradel', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'contacts': [{'name': 'Julia MORERA', 'role': 'CONTACT', 'email': 'morera-j@chu-caen.fr', 'phone': '02 31 06 51 85'}], 'facility': 'CHU de Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'contacts': [{'name': 'Justine CRISTANTE', 'role': 'CONTACT', 'email': 'jcristante@chu-grenoble.fr', 'phone': '04 76 76 55 09'}], 'facility': 'Hôpital Michalon - CHU Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'contacts': [{'name': 'Catherine CARDOT BAUTERS', 'role': 'CONTACT', 'email': 'c-cardo-bauters@chru-lille.fr', 'phone': '03 20 44 43 34'}], 'facility': 'CHU de Lille - Hôpital HURIEZ', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'contacts': [{'name': 'Frederic CASTINETTI', 'role': 'CONTACT', 'email': 'frederic.castinetti@ap-hm.fr', 'phone': '04 91 38 34 79'}], 'facility': 'Hopital de la Conception - Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'contacts': [{'name': 'Isabelle RAINGEARD', 'role': 'CONTACT', 'email': 'i-raingeard@chu-montpellier.fr', 'phone': '04 67 33 83 82'}], 'facility': 'CHU de Montpellier - Hôpital Lapeyronie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'contacts': [{'name': 'Delphine DRUI', 'role': 'CONTACT', 'email': 'delphine.drui@chu-nantes.fr', 'phone': '02 59 48 27 26'}], 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'contacts': [{'name': 'Nicolas Sébastien CHEVALIER', 'role': 'CONTACT', 'email': 'Chevalier.n@chu-nice.fr', 'phone': '04 92 03 96 57'}], 'facility': 'CHU de Nice -Hôpital Archet 2', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Charlotte LUSSEY', 'role': 'CONTACT', 'email': 'charlotte.lussey@aphp.fr', 'phone': '01 42 17 62 81'}], 'facility': 'Hôpital Pitié-Salpêtrière - APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Rossella LIBE', 'role': 'CONTACT', 'email': 'rossella.libe@aphp.fr', 'phone': '01 58 41 32 49'}], 'facility': 'Hôpital Cochin - APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Anne-Paule GIMENEZ ROQUEPLO', 'role': 'CONTACT', 'email': 'anne-paule.gimenez-roqueplo@aphp.fr', 'phone': '01 56 09 38 78'}], 'facility': 'Hôpital européen Georges Pompidou - APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Laurence AMAR', 'role': 'CONTACT', 'email': 'laurence.amar@aphp.fr', 'phone': '01 56 09 37 71'}], 'facility': 'Hôpital européen Georges Pompidou - APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'contacts': [{'name': 'Aurélie MOIT', 'role': 'CONTACT', 'email': 'aurelie.miot@chu-poitiers.fr', 'phone': '05 49 44 40 34'}], 'facility': 'CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '35000', 'city': 'Rennes', 'country': 'France', 'contacts': [{'name': 'Benjamin MOREAU', 'role': 'CONTACT', 'email': 'moreau.benjamin@chu-rennes.fr', 'phone': '02 99 26 71 43'}], 'facility': 'CHU de Rennes - Hôpital Sud', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'contacts': [{'name': 'Bernard GOICHOT', 'role': 'CONTACT', 'email': 'bernard.goichot@chru-strasbourg.fr', 'phone': '03 88 12 75 94'}], 'facility': 'Hôpitaux universitaire de Strasbourg - Hôpital de Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'contacts': [{'name': 'Solange GRUNENWALD', 'role': 'CONTACT', 'email': 'grunenwald.s@chu-toulouse.fr', 'phone': '05 67 77 17 01'}], 'facility': 'CHU de Toulouse - Hôpita Larrey', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37000', 'city': 'Tours', 'country': 'France', 'contacts': [{'name': 'Peggy PIERRE', 'role': 'CONTACT', 'email': 'pierre@med.univ-tours.fr', 'phone': '02 47 47 98 20'}], 'facility': 'CHU Bretonneau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'contacts': [{'name': 'Sophie MOOG', 'role': 'CONTACT', 'email': 'Sophie.moog@gustaveroussy.fr', 'phone': '01 42 11 24 07'}], 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'centralContacts': [{'name': 'Alexandre Buffet, MD, PhD', 'role': 'CONTACT', 'email': 'alexandre.buffet@aphp.fr', 'phone': '33-1-56093879'}, {'name': 'Anne-Paule Gimenez-Roqueplo, MD, PhD', 'role': 'CONTACT', 'email': 'anne-paule.gimenez-roqueplo@aphp.fr', 'phone': '33-1-56093881'}], 'overallOfficials': [{'name': 'Anne-Paule Gimenez-Roqueplo, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hôpital européen Georges Pompidou - APHP'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Two years after the last publication', 'ipdSharing': 'YES', 'description': 'Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared', 'accessCriteria': '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).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, {'name': 'ANSES', 'class': 'OTHER'}, {'name': 'Centre Leon Berard', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}