Ignite Creation Date:
2025-12-17 @ 1:45 PM
Ignite Modification Date:
2025-12-23 @ 4:53 PM
Study NCT ID:
NCT01211561
Status:
UNKNOWN
Last Update Posted:
2010-09-29
First Post:
2010-09-28
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Colon Cancer Prevention Using Selenium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012643', 'term': 'Selenium'}, {'id': 'D012645', 'term': 'Selenomethionine'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008903', 'term': 'Minerals'}, {'id': 'D016566', 'term': 'Organoselenium Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008715', 'term': 'Methionine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-09-28', 'studyFirstSubmitDate': '2010-09-28', 'studyFirstSubmitQcDate': '2010-09-28', 'lastUpdatePostDateStruct': {'date': '2010-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in ACF biomarkers', 'timeFrame': '6 months'}]}, 'conditionsModule': {'conditions': ['Prevention of Colorectal Cancer']}, 'descriptionModule': {'briefSummary': "Selenium's ability to prevent colorectal cancer (CRC) has been suspected for nearly 30 years, but has never been directly studied in humans. The investigators will directly assess selenium's ability to prevent CRC by measuring alterations in aberrant crypt foci (ACF), an accepted surrogate marker for CRC.\n\nACF's are very small (i.e., microscopic) collections of abnormally shaped cells that are a commonly used marker of CRC risk. Screening colonoscopy at UIC routinely uses methods that allow ACF counting to be done as a part of standard practice. ACF's are not fixed, like polyps or cancers, but can disappear as a person's risk for developing CRC decreases.\n\nThe investigators propose giving patient's with 6 or more ACF's 200 mcg selenized yeast or placebo, and determining if there is a drug-dependant decrease in ACF number. The primary objective is to determine whether selenized yeast supplementation, compared to placebo, causes significant reduction of ACF number from baseline levels. The primary endpoint will be change in ACF number"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All non-pregnant patients \\>50 years of age\n\nExclusion Criteria:\n\n* The following will be specifically looked for, and result in patients not being eligible for study enrollment:\n\n * Use of non-steroidal anti-inflammatory drugs or glucocorticosteroids within 60 days of study entry.\n * History of chronic IBD or prior pelvic radiation (inflammation distorts crypt pattern).\n * Intake of any selenium supplements within 60 days of study entry, including vitamins.\n * Patients with increased bleeding risk from biopsy protocol (i.e. renal failure, decompensated cirrhosis, blood dyscrasia).'}, 'identificationModule': {'nctId': 'NCT01211561', 'briefTitle': 'Colon Cancer Prevention Using Selenium', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'orgStudyIdInfo': {'id': '2008-1122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Selenium, selenomethionine', 'interventionNames': ['Drug: Selenium, selenomethionine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Selenium, selenomethionine', 'type': 'DRUG', 'description': 'Patients will receive one 200 ug pill of Selenomethionine', 'armGroupLabels': ['Selenium, selenomethionine']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Patients will be given one 200 ug placebo pill each day for 6 months', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'contacts': [{'name': 'John OToole, BA', 'role': 'CONTACT', 'phone': '312-413-2446'}], 'facility': 'University of Illinois at Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': "John A O'Toole, BA", 'role': 'CONTACT', 'email': 'jotool2@uic.edu', 'phone': '312-413-2446'}], 'overallOfficials': [{'name': 'Richard V Benya, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Richard Benya', 'oldOrganization': 'University of Illinois'}}}}