Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-01-01 @ 10:10 AM
Study NCT ID:
NCT01720368
Status:
COMPLETED
Last Update Posted:
2015-08-17
First Post:
2012-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OPERA Database - Crohn's Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-14', 'studyFirstSubmitDate': '2012-10-31', 'studyFirstSubmitQcDate': '2012-11-01', 'lastUpdatePostDateStruct': {'date': '2015-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validity of patient self reporting', 'timeFrame': '12 months', 'description': "The validity of patient self report on details of their Crohn's disease compared to chart review. Validity is defined as a match between patient self report and medical records."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IBD', "Crohn's"], 'conditions': ['Inflammatory Bowel Disease', "Crohn's Disease"]}, 'descriptionModule': {'briefSummary': "The investigators believe that patients with Crohn's disease are able to report details of their own medical history accurately and record changes in clinical status effectively over time. Using an internet-based database the investigators will ask patients to report their own disease history, and the investigators will compare their reports to the medical record."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Men and women over 18 years of age with Crohn's disease", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults (over 18 years of age) with physician diagnosed Crohn's disease\n* A current or past prescription of anti-TNF\n* Access to medical record for validation of clinical information\n\nExclusion Criteria:\n\n* Unwilling or unable to provide informed consent for study participation\n* Unable to access or use the internet\n* Ulcerative colitis or IBD-U\n* Illiterate or does not possess minimum level of literacy required to complete questionnaire"}, 'identificationModule': {'nctId': 'NCT01720368', 'acronym': 'OPERA', 'briefTitle': "OPERA Database - Crohn's Protocol", 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': "IBD-OPERA Database IBD OPERA Database: Inflammatory Bowel Disease - Outcomes, Preferences, Education, Resource Utilization, Assessment Database - Crohn's Protocol", 'orgStudyIdInfo': {'id': 'IMM 10-0162'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1st Group of 50 patients'}, {'label': '2nd Group of 50 patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}