Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-01-27 @ 5:09 PM
Study NCT ID:
NCT02514057
Status:
WITHDRAWN
Last Update Posted:
2021-05-04
First Post:
2015-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastrointestinal Symptom Questionnaire Validation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'investigator emigrated', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-28', 'studyFirstSubmitDate': '2015-07-31', 'studyFirstSubmitQcDate': '2015-07-31', 'lastUpdatePostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Construct validity measured by Validation of new score', 'timeFrame': '18 months', 'description': 'Validation of new score'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Those With and Without Gastrointestinal Disorders']}, 'descriptionModule': {'briefSummary': 'Assessment of a new gastrointestinal symptom questionnaire in comparison to 2 well established and validated questionnaires that do not fully fit the requirements of an investigator concerned about gastrointestinal side effects in a patient without primary gastrointestinal disease.', 'detailedDescription': '210 subjects Healthy (n=70), ill with non-GI disease (n=70), with GI disease (n=70) Age above 18 COnsent after full explanation Each subject completes 3 questionnaires Glasgow Dyspepsia Score Gastrointestinal Symptom Rating Scale New score This is a total of 48 questions Analysis will seek to validate the new score. There is no other intervention and no risks are anticipated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'As above', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* As above Either healthy or GI disease or non-GI disease\n\nExclusion Criteria:\n\n* Unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT02514057', 'briefTitle': 'Gastrointestinal Symptom Questionnaire Validation', 'organization': {'class': 'OTHER', 'fullName': 'University of East Anglia'}, 'officialTitle': 'Gastrointestinal Symptom Questionnaire Validation', 'orgStudyIdInfo': {'id': '150725'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy', 'description': 'Volunteers over 18 years', 'interventionNames': ['Other: Questionnaire']}, {'label': 'Gastrointestinal disorders', 'description': 'Over 18 and with any gastrointestinal or liver disorder', 'interventionNames': ['Other: Questionnaire']}, {'label': 'Non-gastrointestinal disorders', 'description': 'Over 18 and with any medical condition requiring hospital attention in which there is no primary gastrointestinal or liver disease', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Form filling only', 'armGroupLabels': ['Gastrointestinal disorders', 'Healthy', 'Non-gastrointestinal disorders']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Alastair Forbes, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'UEA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of East Anglia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}