Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT05022420
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2021-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SAfety and TOlerance of the Biopsies in Auto-immune Rare dIseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-02-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2021-08-25', 'studyFirstSubmitQcDate': '2021-08-25', 'lastUpdatePostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tolerance of each type of biopsy', 'timeFrame': 'tolerance at day 7 after the biospy was performed', 'description': "tolerance based on a standardized patient 's questionnaire"}], 'secondaryOutcomes': [{'measure': 'tolerance of each type of biopsy 30 days after', 'timeFrame': 'tolerance at day 30 and at inclusion after the biospy was performed', 'description': "tolerance based on a standardized patient 's questionnaire"}, {'measure': "evaluation of the qualitiy of patient's information at inclusion", 'timeFrame': 'questionnaire at inclusion', 'description': 'standardized questionnaire at inclusion'}, {'measure': 'risk factor of sied effect of each biospy', 'timeFrame': 'standardized questionnaire at inclusion, day 7 and 30', 'description': 'standardized questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tolerance', 'Biopsy Site Itching']}, 'descriptionModule': {'briefSummary': 'Biopsies are performed in several autoimmune diseases to diagnose or classify them Tolerance and information of the patients have been poorly evlauated our objective is to evaluate tolerance and information of the patients after the biopsies for salivary gland, temporal arteries and neuromuscular.', 'detailedDescription': 'patinets that benefited of arterial temporal biospy or salivary gland biospy or muscuar biopsy or neuro muscular biospy for his auto -mmune disease will be included and fill standardized questionnaires concerning tolerance, information and side effect at inclusion , day 7 and day 30 after the biopsy data will be analysed to evaluate information, tolerance and risk factor af side effect'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'all patients that underwent a biospy for his auto-immune rare disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* biospy required for the diagnsis or follow up aged of more than 18 non opposition form\n\nExclusion Criteria:\n\n* unable to consent demencia unable to fill the form and questionnaire patient Under juridical protection refusing to participate'}, 'identificationModule': {'nctId': 'NCT05022420', 'acronym': 'SATORI', 'briefTitle': 'SAfety and TOlerance of the Biopsies in Auto-immune Rare dIseases', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'SAfety and TOlerance of the Biopsies in Auto-immune Rare dIseases', 'orgStudyIdInfo': {'id': 'SATORI (29BRC21.0089)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Salivary gland biospy,', 'description': '100 Salivary gland biospy use for the diagnosis of sjogern disease or other auto-immune disease.'}, {'label': 'muscular biopsy,', 'description': 'muscular biospy use for the diagnosis of muscular auto-immune disease.'}, {'label': 'neuro muscular biospy', 'description': 'neuro muscular biospy use for the diagnosis of vasculitis,muscular auto-immune disease or neuro-muscumar auto-immune disease'}, {'label': 'temporal arteries biospy', 'description': 'temporal arteries biospy uses for the diagnosis of giant cell arteritis'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Geoffrey URBANSKI', 'role': 'CONTACT'}], 'facility': "CHU d'ANGERS", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '33000', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christophe RICHEZ RICHEZ', 'role': 'CONTACT'}], 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '29609', 'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Valerie Devauchelle-Pensec', 'role': 'CONTACT', 'email': 'valerie.devauchelle-pensec@chu-brest.fr'}], 'facility': 'CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '59037', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eric HACHULLA', 'role': 'CONTACT'}], 'facility': 'CHU de LILLE', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Marseille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuelle CAMPANA-SALORT -', 'role': 'CONTACT'}], 'facility': 'CHU de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '75013', 'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yves ALLENBACH', 'role': 'CONTACT'}], 'facility': 'Hôpital de la Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '20007', 'city': 'Quimper', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jérémy KERAËN', 'role': 'CONTACT', 'email': 'jeremy.keraen@ch-cornouaille.fr'}], 'facility': 'CH de Quimper', 'geoPoint': {'lat': 47.99597, 'lon': -4.09795}}, {'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillermo CARVAJAL ALEGRIA', 'role': 'CONTACT'}], 'facility': 'CHU de Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Valérie Devauchelle-Pensec', 'role': 'CONTACT', 'email': 'valerie.devauchelle-pensec@chu-brest.fr', 'phone': '02-98-34-72-64'}, {'name': 'Alain Saraux', 'role': 'CONTACT', 'email': 'alain.saraux@chu-brest.fr', 'phone': '02 98 34 72 64'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available beginning one year and ending five years following the publication', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}