Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-03-30 @ 1:01 PM
Study NCT ID:
NCT02269332
Status:
COMPLETED
Last Update Posted:
2024-01-22
First Post:
2014-10-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vitamin D and Screening Colonoscopy or Polyp Surveillance
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amanda.j.crawford.ctr@health.mil', 'phone': '7026533583', 'title': 'Senior Research Associate/Research Manager', 'organization': "Mike O'Callaghan Military Medical Center"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Screening Colonoscopy', 'description': 'Referred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks\n\nScreening Colonoscopy: we will obtain serum vitamin D blood levels from those scheduled for a screening colonoscopy or polyp surveillance', 'otherNumAtRisk': 298, 'deathsNumAtRisk': 298, 'otherNumAffected': 0, 'seriousNumAtRisk': 298, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Serum Vitamin D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Screening Colonoscopy', 'description': 'Referred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks\n\nScreening Colonoscopy: we will obtain serum vitamin D blood levels from those scheduled for a screening colonoscopy or polyp surveillance'}], 'classes': [{'categories': [{'title': 'vitamin D insufficiency (<30ng/ml)', 'measurements': [{'value': '155', 'groupId': 'OG000'}]}, {'title': 'vitamin D normal (>30ng/ml)', 'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks', 'description': 'Vitamin D blood levels will be obtained at the time of procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Adenomatous Polyps', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Screening Colonoscopy', 'description': 'Referred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks\n\nScreening Colonoscopy: we will obtain serum vitamin D blood levels from those scheduled for a screening colonoscopy or polyp surveillance'}], 'classes': [{'title': 'found to have adenomatous polyps', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}]}]}, {'title': 'did not have adenomatous polyps', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Screening Colonoscopy', 'description': 'Referred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks\n\nScreening Colonoscopy: we will obtain serum vitamin D blood levels from those scheduled for a screening colonoscopy or polyp surveillance'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '298'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'number analyzed', 'groupId': 'FG000', 'numSubjects': '228'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Screening Colonoscopy', 'description': 'Referred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks\n\nScreening Colonoscopy: we will obtain serum vitamin D blood levels from those scheduled for a screening colonoscopy or polyp surveillance'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '298', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '134', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '164', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 298}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-19', 'studyFirstSubmitDate': '2014-10-14', 'resultsFirstSubmitDate': '2020-06-22', 'studyFirstSubmitQcDate': '2014-10-20', 'lastUpdatePostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-19', 'studyFirstPostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Vitamin D', 'timeFrame': '2 weeks', 'description': 'Vitamin D blood levels will be obtained at the time of procedure.'}, {'measure': 'Adenomatous Polyps', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colon Cancer']}, 'descriptionModule': {'briefSummary': 'The investigators will recruit DoD beneficiaries 18 years or older, that have been referred for a screening colonoscopy or polyp surveillance (or had one in the last 2 weeks), and have no previous diagnosis of colorectal cancer. They will have a 25 OH Vitamin D level drawn to determine if there is an association between the level obtained and findings on colonoscopy, or previous findings (if repeating).', 'detailedDescription': "DoD beneficiaries age 18 or older will be recruited from the clinics at the Mike O'Callaghan Federal Medical Center (MOFMC). Subjects meeting the inclusion/exclusion criteria will be offered an opportunity to participate:\n\nScreening Visit:\n\n* Obtain signed Informed Consent Document and HIPAA Authorization (research-driven).\n* Record: Date of birth, age, gender, race, ethnicity, current email address, height (in inches), weight (in pounds), waist circumference (in inches) measurement, blood pressure, and whether subject is taking or has taken any vitamin D supplement or derivative, and if so, note the dosage, frequency, and duration of therapy.\n* Subjects will be told to fast for at least 10 hours prior to Visit 1\n\nVisit 1 (within two weeks of their screening colonoscopy):\n\n-Subjects will have the following research-driven blood test drawn which include: Serum 25-OH vitamin D via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "DoD beneficiaries age 18 or older will be recruited from the clinics at the Mike O'Callaghan Federal Medical Center (MOFMC). Subjects meeting the inclusion/exclusion criteria will be offered an opportunity to participate.", 'healthyVolunteers': False, 'eligibilityCriteria': 'THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.\n\nInclusion:\n\n* DoD beneficiaries 18 years or older\n* Referred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks\n\nExclusion:\n\n* Previous diagnosis of colorectal cancer, adenomatous polyps, and/or cancer\n* Military trainees\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT02269332', 'acronym': 'VitDColon', 'briefTitle': 'Vitamin D and Screening Colonoscopy or Polyp Surveillance', 'organization': {'class': 'FED', 'fullName': "Mike O'Callaghan Military Hospital"}, 'officialTitle': 'Association of 25-OH Vitamin D Status With Findings on Screening Colonoscopy.', 'orgStudyIdInfo': {'id': 'FWH20140085H'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Screening Colonoscopy', 'description': 'Referred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks', 'interventionNames': ['Other: Screening Colonoscopy']}], 'interventions': [{'name': 'Screening Colonoscopy', 'type': 'OTHER', 'description': 'we will obtain serum vitamin D blood levels from those scheduled for a screening colonoscopy or polyp surveillance', 'armGroupLabels': ['Screening Colonoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89191', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': "Mike O'Callaghan Federal Hospital/Nellis Air Force Base", 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}], 'overallOfficials': [{'name': 'Carl Bryce, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Mike O'Callaghan Federal Medical Center"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Mike O'Callaghan Military Hospital", 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}