Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-03-04 @ 2:18 AM
Study NCT ID:
NCT01928667
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2013-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Case-Control Study to Identify Risk Factors for Microscopic Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046728', 'term': 'Colitis, Microscopic'}, {'id': 'D046729', 'term': 'Colitis, Collagenous'}, {'id': 'D046730', 'term': 'Colitis, Lymphocytic'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'saliva samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 487}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-18', 'studyFirstSubmitDate': '2013-08-21', 'studyFirstSubmitQcDate': '2013-08-21', 'lastUpdatePostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of environmental and hygiene-related risk factors for microscopic colitis', 'timeFrame': 'Retrospective, between 2000 and 2012', 'description': 'Information about environmental and hygiene-related risk factors is obtained by a questionnaire, sent to subjects diagnosed with MC between 2000 and 2012'}], 'secondaryOutcomes': [{'measure': 'The difference between the CC and LC subpopulation regarding environmental, hygiene-related, and generally known risk factors', 'timeFrame': 'Retrospective between 2000 and 2012', 'description': 'As generally known risk factors are considered: age, gender, medication, comorbidities and smoking.\n\nInformation about risk factors is obtained by a questionnaire, sent to subjects diagnosed with MC between 2000 and 2012.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Microscopic Colitis', 'Collagenous Colitis', 'Lymphocytic Colitis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess among others environmental and hygiene-related risk factors for microscopic colitis (MC), a common diarrheal disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The case group will be selected by a retropective search in the pathology registry. Subjects have to be diagnosed between January 1, 2000 and December 31, 2012; have to be older than 18 years of age and have to be living in the province of Limburg, the Netherlands.\n\nHealthy controls are selected via the municipal personal records databases in the same region.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed Diagnosis of MC (CC or LC) between January 1, 2000 and December 31, 2012.\n* Inhabitant of the province of Limburg or the Eindhoven region at the moment of diagnosis\n\nExclusion Criteria:\n\n* Below 18 years of age at the time of diagnosis\n* Not capable of signing an informed consent\n* Deceased at moment of approximation'}, 'identificationModule': {'nctId': 'NCT01928667', 'briefTitle': 'Case-Control Study to Identify Risk Factors for Microscopic Colitis', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Risk Factors for Microscopic Colitis: A Dutch Case-Control Study', 'orgStudyIdInfo': {'id': 'NL44127.068.13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Microscopic Colitis', 'description': 'Group consists of subjects diagnosed with either collagenous of lymphocytic colitis between January 1, 2000 and December 31, 2012', 'interventionNames': ['Other: Whole saliva sample']}, {'label': 'Healthy Controls', 'description': 'Control group consists of subjects with no history of microscopic colitis. Group is age and sex matched with the case-group', 'interventionNames': ['Other: Whole saliva sample']}], 'interventions': [{'name': 'Whole saliva sample', 'type': 'OTHER', 'description': 'Both case and control group will be approached to consider to give permission to sample saliva. This is not obligatory. Collected samples will be stored for future DNA research.', 'armGroupLabels': ['Healthy Controls', 'Microscopic Colitis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht UMC', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Marieke J Pierik, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht UMC'}, {'name': 'Daisy MAE Jonkers, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University'}, {'name': 'Ad AM Masclee, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Maastricht UMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}