Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT03566004
Status:
COMPLETED
Last Update Posted:
2020-07-17
First Post:
2018-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Performances of a H. Pylori Stool PCR Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-16', 'studyFirstSubmitDate': '2018-02-27', 'studyFirstSubmitQcDate': '2018-06-11', 'lastUpdatePostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of H. pylori by culture or glmM real-time PCR', 'timeFrame': 'Day 2'}, {'measure': 'Detection of H. pylori by culture or glmM real-time PCR', 'timeFrame': 'Day30'}, {'measure': 'Detection of clarithromycin resistance by E-test or Scorpion PCR from gastric biopsies.', 'timeFrame': 'Day 2'}, {'measure': 'Detection of clarithromycin resistance by E-test or Scorpion PCR from gastric biopsies.', 'timeFrame': 'Day 30'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Helicobacter Pylori']}, 'descriptionModule': {'briefSummary': 'Performance of a non-invasive test for the detection of Helicobacter pylori and its resistance to clarithromycin in stool by Real-Time PCR Amplidiag H. pylori + ClariR (Mobidiag).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* indication of endoscopy with biopsies for H. pylori infection\n* Free subject, without tutorship or curatorship or subordination\n* Patients benefiting from a social security scheme or benefiting through a third party\n* Consent informed and signed by the patient after clear and fair information about the study\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Contraindications to fibroscopy (suspicion of oesophageal perforation)\n* Antibiotic intake less than 4 weeks old\n* Diarrheal patients during sampling\n* Patients who do not benefit from a social security scheme or who do not benefit from it through a third party\n* Persons enjoying enhanced protection, namely minors, pregnant women, breastfeeding, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergency situation.\n* Pregnant or lactating women, women of childbearing potential who do not have effective contraception (hormonal / mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy )'}, 'identificationModule': {'nctId': 'NCT03566004', 'acronym': 'HEPYSTOOL', 'briefTitle': 'Performances of a H. Pylori Stool PCR Test', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'Performance of a Non-invasive Test for the Detection of Helicobacter Pylori and Its Resistance to Clarithromycin in Stool by Real-Time PCR Amplidiag H. Pylori + ClariR (Mobidiag)', 'orgStudyIdInfo': {'id': 'HEPYSTOOL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'endoscoped patients', 'description': 'Patients addressed for endoscopy with indication of biopsies for H. pylori detection will be enroled to provide stool specimen', 'interventionNames': ['Diagnostic Test: Stool specimen collection']}], 'interventions': [{'name': 'Stool specimen collection', 'type': 'DIAGNOSTIC_TEST', 'description': 'The stool specimen collection was performed at the hospital or at home using a disposable device to be placed on the toilet seat and an E-nat Tube sent by postal to the lab.', 'armGroupLabels': ['endoscoped patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Poitiers', 'country': 'France', 'facility': 'CHU DE Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}], 'overallOfficials': [{'name': 'Christophe BURUCOA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Poitiers University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}