Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-03-02 @ 6:07 PM
Study NCT ID:
NCT03060733
Status:
COMPLETED
Last Update Posted:
2019-02-07
First Post:
2017-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Helicobacter Pylori Sample Collection Protocol Post Therapy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013276', 'term': 'Stomach Ulcer'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D015746', 'term': 'Abdominal Pain'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D000855', 'term': 'Anorexia'}], 'ancestors': [{'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000359', 'term': 'Aftercare'}], 'ancestors': [{'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011320', 'term': 'Primary Health Care'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Human Stool'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-06', 'studyFirstSubmitDate': '2017-02-15', 'studyFirstSubmitQcDate': '2017-02-17', 'lastUpdatePostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Helicobacter pylori Stool Collection', 'timeFrame': 'Through Study Completion, an average of 1 year', 'description': 'In vitro diagnostic (IVD) device performance'}]}, 'oversightModule': {'isFdaRegulatedDrug': False}, 'conditionsModule': {'conditions': ['Helicobacter Pylori Infection', 'Gastric Ulcer', 'Nausea', 'Abdominal Pain', 'Weight Loss', 'Stomach Ulcer', 'Loss of Appetite', 'Bloating']}, 'descriptionModule': {'briefSummary': 'The primary objective is to obtain stool samples from post-therapy subjects already undergoing evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD) and gastric biopsy.', 'detailedDescription': 'Stools will be collected and tested, at a later date, in a clinical performance study with an investigational H. pylori antigen assay. This study will be coordinated by the Sponsor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects are evaluated for H. pylori infectious status prior to eligibility. Evaluation includes use of a diagnostic H. pylori test, such as, an FDA cleared UBT or an FDA cleared Fecal Stool Antigen. Infectious status must be determined positive for H. pylori for subject eligibility.\n\nEligible subjects are undergoing EGD with biopsy for H. pylori infectious status after completion of therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult ≥ 22 years, either gender\n* Subject previously diagnosed with H. pylori infection\n* Subject received and completed FDA approved treatment option\n* Minimum of 4 weeks to one year has lapsed after completion of FDA approved treatment option\n* Subject with a post therapy positive result from a FDA cleared UBT or FDA cleared Fecal Antigen Test\n* Subject will undergo EGD and gastric biopsy as part of routine care to measure H. pylori post-therapy response\n* Biopsy is obtained from antrum and/or corpus and is tested by CRM\n* At least two of the three CRM tests are performed\n* Subject whose EGD with biopsy occurred ≤ 7 days prior to stool collection\n* Willing and able to sign the IRB approved Informed Consent form for this study project\n\nExclusion Criteria:\n\n* Subject with current severe H. pylori infection\n* Subject ingested compounds that may interfere with detecting of H. pylori, e.g. 4 weeks for antibiotics and 2 weeks for Bismuth preparations or proton pump inhibitors prior to collection\n* Pregnant or lactating\n* Inability or unwilling to perform required study procedures\n* Subject is unable or unwilling to provide informed consent'}, 'identificationModule': {'nctId': 'NCT03060733', 'briefTitle': 'Helicobacter Pylori Sample Collection Protocol Post Therapy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'DiaSorin Inc.'}, 'officialTitle': 'Helicobacter Pylori Sample Collection Protocol POST-THERAPY', 'orgStudyIdInfo': {'id': 'POST-TREAT Z001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Post-Therapy', 'type': 'OTHER', 'description': 'Gastric biopsy tested by composite reference method (CRM) (histology, urease, culture) and stool sample'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91345', 'city': 'Mission Hills', 'state': 'California', 'country': 'United States', 'facility': 'One (1) Location in California', 'geoPoint': {'lat': 34.68609, 'lon': -120.43683}}, {'zip': '11023', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'One (1) Location in Great Neck, New York', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 'United States', 'facility': 'One (1) Location in Ohio', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'One (1) Location in Houston, Texas', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Bologna', 'country': 'Italy', 'facility': 'One (1) Location in Bologna, Italy', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DiaSorin Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ICON Clinical Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}