Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-01-03 @ 10:20 PM
Study NCT ID:
NCT02243267
Status:
COMPLETED
Last Update Posted:
2017-11-08
First Post:
2014-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GI SPORE Colon Biosample Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal 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'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum Plasma Buffy Coat Tissue Stool Urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-06', 'studyFirstSubmitDate': '2014-09-11', 'studyFirstSubmitQcDate': '2014-09-16', 'lastUpdatePostDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'New Biomarker for colon cancer detection', 'timeFrame': '6 years', 'description': 'To create a longitudinal biorepository from individuals with colorectal cancer, those who are high risk for developing colorectal cancer, and screened, endoscopically normal controls including a reference set of well annotated, pathologically confirmed tissue, plasma, serum, and white blood cell biosamples and corresponding demographic, risk, and clinical treatment data for improved colon cancer detection.'}, {'measure': 'Response to Treatment', 'timeFrame': '6 years', 'description': 'To create a longitudinal biorepository from individuals with colorectal cancer, those who are high risk for developing colorectal cancer, and screened, endoscopically normal controls including a reference set of well annotated, pathologically confirmed tissue, plasma, serum, and white blood cell biosamples and corresponding demographic, risk, and clinical treatment data for improved colon cancer detection.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Colon Cancer Colon Cancer Prevention'], 'conditions': ['Colon Cancer', 'Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'The investigators are creating a data and specimen repository to study causes , early detection, prevention and treatment of colon and rectal cancer. The investigators are collecting data and specimens (blood, stool, urine and tissue) from people who have colon or rectal cancer, or who are risk for developing colorectal cancer or had normal colonoscopies. Data and samples are held in the repository until there are enough to be used for a large study or until there are new techniques that can be used to test them. The GI SPORE Program at the University of Michigan maintains a repository of specimens for colorectal diseases that the investigators hope will help fuel new research. The investigators hope that this work may lead to new treatments or earlier detection of colorectal cancer or improved diagnosis and treatment of other colon and rectal diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of the University of Michigan Health System', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n5.2 General Eligibility Criteria 5.2.1 Overall Inclusion\n\n1. Adults 18 years of age or older\n2. Willing to sign informed consent.\n3. Able to tolerate removal of up to 50 ml of blood\n\n5.2.2 Overall Exclusion Criteria\n\n1. Pregnant, lactating\n2. Unable to understand English\n3. Known HIV/AIDS or Hepatitis C\n\n5.3 Disease or Control Specific Eligibility Criteria 5.3.1 Unaffected Healthy Individuals (Healthy Controls)\n\n1. No prior colorectal neoplasia\n2. Undergoing colonoscopy in the next 3-4 months OR had an endoscopically normal colonoscopy within the previous 6 months.\n3. Not prepped for colonoscopy at the time of blood draw\n4. No personal history of colorectal cancer\n5. No personal history of other cancers in the last 5 years (except basal/squamous skin lesions)\n\n5.3.2 Prior non-invasive colorectal neoplasia (Adenoma surveillance)\n\n1. Personal history of one or more adenomas or sessile serrated polyps in colon\n2. Undergoing colonoscopy in the next 3-4 months\n3. Not prepped for colonoscopy at the time of blood draw\n4. No personal history of colorectal cancer\n5. No personal history of other cancers in the last 5 years (except basal/squamous skin lesions)\n\n5.3.3 New Diagnosis of Colon Adenocarcinoma (untreated, new colon CA)\n\n1. Newly diagnosed colon adenocarcinoma, any stage\n2. No treatment received yet\n3. Not prepped for colonoscopy or surgery at the time of blood draw\n\n5.3.4 New Diagnosis of Rectal Adenocarcinoma (untreated, new rectal CA)\n\n1. Newly diagnosed rectal adenocarcinoma, any stage\n2. No treatment received yet\n3. Not prepped for colonoscopy or surgery at the time of blood draw\n\n5.3.5 Colorectal Cancer (less than 5 years ago) (current/recent CRC)\n\n1. Personal history of colorectal adenocarcinoma within the last 5 years\n2. Not prepped for colonoscopy at the time of blood draw\n3. No personal history of other cancers in the last 5 years (except basal/squamous skin lesions)\n\n5.3.6 Colorectal Cancer (greater than 5 years ago)(remote history of colorectal cancer)\n\n1. Personal history of colorectal adenocarcinoma greater than 5 years ago\n2. Not prepped for colonoscopy at the time of blood draw\n\n5.3.7 Hereditary Cancer syndrome (confirmed or suspected) (genetic risk of colorectal cancer)\n\n1. Personal or family history which meets clinical criteria for genetic evaluation for a hereditary cancer syndrome\n2. Not prepped for colonoscopy at the time of blood draw'}, 'identificationModule': {'nctId': 'NCT02243267', 'briefTitle': 'GI SPORE Colon Biosample Protocol', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Biospecimens for the Diagnosis, Treatment and Prevention of Colorectal Cancer', 'orgStudyIdInfo': {'id': 'HUM00064405'}}, 'armsInterventionsModule': {'interventions': [{'name': 'sample collection', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Project manager', 'investigatorFullName': 'Missy Tuck', 'investigatorAffiliation': 'University of Michigan'}}}}