Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-31 @ 5:31 AM
Study NCT ID:
NCT00003833
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
1999-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic Study in Patients With Stage II or Stage III Colon Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'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': 'D002874', 'term': 'Chromosome Mapping'}], 'ancestors': [{'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Normal and tumor tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 598}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-12', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2016-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'Up to 10 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage II colon cancer', 'stage III colon cancer', 'adenocarcinoma of the colon'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Genetic studies may help in understanding the genetic processes that cause some types of cancer.\n\nPURPOSE: Genetic trial to study certain genes of patients who have stage II or stage III colon cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the adverse prognostic significance of 8p allelic imbalance (AI) in patients with colon cancer.\n* Determine if patient prognosis is dependent on the region of 8p AI.\n* Perform fine mapping studies to further localize the putative tumor suppressor gene(s) on 8p.\n* Perform multicolor FISH to examine the role that 8p loss and 8q gain play in the prognosis of patients whose tumors exhibit 8p AI.\n\nOUTLINE: Matched normal and tumor DNA is analyzed for 8p allelic imbalance with at least 8 markers: D8S262 and D8S1825 localized to 8p23, D8S254 and D8S261 at 8p22, D8S560 and D8S136 at 8p21, and D8S1820 and D8S283 at 8p12. Normal/tumor tissue pairs are used for fine mapping studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with advanced colon cancer previously participating in NCCTG-914653.', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of resectable stage II or III adenocarcinoma of the colon\n* Participated in NCCTG-914653\n* DNA extracted from both normal and tumor tissue\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Under 70'}, 'identificationModule': {'nctId': 'NCT00003833', 'briefTitle': 'Genetic Study in Patients With Stage II or Stage III Colon Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'The Clinical and Pathological Significance of Allelic Imbalance of 8p in Patients With Colorectal Cancer', 'orgStudyIdInfo': {'id': 'NCCTG-984654'}, 'secondaryIdInfos': [{'id': 'CDR0000066990', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'CAN-NCIC-CO9PATH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal and tumor tissue pairs', 'description': 'Matched normal and tumor DNA is analyzed for 8p allelic imbalance with at least 8 markers: D8S262 and D8S1825 localized to 8p23, D8S254 and D8S261 at 8p22, D8S560 and D8S136 at 8p21, and D8S1820 and D8S283 at 8p12. Normal/tumor tissue pairs are used for fine mapping studies.', 'interventionNames': ['Genetic: DNA stability analysis', 'Genetic: gene mapping']}], 'interventions': [{'name': 'DNA stability analysis', 'type': 'GENETIC', 'armGroupLabels': ['Normal and tumor tissue pairs']}, {'name': 'gene mapping', 'type': 'GENETIC', 'armGroupLabels': ['Normal and tumor tissue pairs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55805', 'city': 'Duluth', 'state': 'Minnesota', 'country': 'United States', 'facility': "St. Mary's/Duluth Clinic Health System", 'geoPoint': {'lat': 46.78327, 'lon': -92.10658}}, {'zip': 'T2N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Tom Baker Cancer Center - Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T1J 1W5', 'city': 'Lethbridge', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Lethbridge Cancer Clinic', 'geoPoint': {'lat': 49.69999, 'lon': -112.81856}}, {'zip': 'V9S 2B7', 'city': 'Nanaimo', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Nanaimo Cancer Clinic', 'geoPoint': {'lat': 49.16638, 'lon': -123.94003}}, {'zip': 'V3V 1Z2', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Cancer Agency - Fraser Valley Cancer Centre', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'V5Z 3J5', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Prostate Centre at Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Cancer Agency', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St. Paul's Hospital - Vancouver", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V8V 3N1', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'G. Steinhoff Clinical Research', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'E1C 6ZB', 'city': 'Moncton', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Moncton Hospital', 'geoPoint': {'lat': 46.09454, 'lon': -64.7965}}, {'zip': 'E1C 8X3', 'city': 'Moncton', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Doctor Leon Richard Oncology Centre', 'geoPoint': {'lat': 46.09454, 'lon': -64.7965}}, {'zip': 'E2L 4L2', 'city': 'Saint John', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Saint John Regional Hospital', 'geoPoint': {'lat': 45.27076, 'lon': -66.05616}}, {'zip': 'A1B 3V6', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Newfoundland Cancer Treatment and Research Foundation', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'B3H 1V7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Nova Scotia Cancer Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'B1P 1P3', 'city': 'Sydney', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Cape Breton Cancer Centre', 'geoPoint': {'lat': 46.1351, 'lon': -60.1831}}, {'zip': 'L4M 6M2', 'city': 'Barrie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Royal Victoria Hospital, Barrie', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}, {'zip': 'L6W 2Z8', 'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'William Osler Health Centre', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'P3E 5J1', 'city': 'Greater Sudbury', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Northeastern Ontario Regional Cancer Centre, Sudbury', 'geoPoint': {'lat': 46.49, 'lon': -80.99001}}, {'zip': 'L8N 1T8', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton and District Urology Association', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 4G5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L3P 7T3', 'city': 'Markham', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Markham Stouffville Hospital', 'geoPoint': {'lat': 43.86682, 'lon': -79.2663}}, {'zip': 'L5B 1B8', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Trillium Health Centre', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'L5M 2N1', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Credit Valley Hospital', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'L3Y 2P9', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'York County Hospital', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'M2K 1E1', 'city': 'North York', 'state': 'Ontario', 'country': 'Canada', 'facility': 'North York General Hospital, Ontario'}, {'zip': 'L6H 3PI', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Male Health Centre/CMX Research Inc.', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}, {'zip': 'L1G 2B9', 'city': 'Oshawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Lakeridge Health Oshawa', 'geoPoint': {'lat': 43.90012, 'lon': -78.84957}}, {'zip': 'K1H 1C4', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Regional Cancer Centre', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'K9H 7B6', 'city': 'Peterborough', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Peterborough Oncology Clinic', 'geoPoint': {'lat': 44.30012, 'lon': -78.31623}}, {'zip': 'M1P 2V5', 'city': 'Scarborough Village', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Scarborough Hospital - General Site', 'geoPoint': {'lat': 43.73899, 'lon': -79.22124}}, {'zip': 'L2R 5K3', 'city': 'St. Catharines', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hotel Dieu Health Sciences Hospital - Niagara', 'geoPoint': {'lat': 43.17126, 'lon': -79.24267}}, {'zip': 'P7A 7T1', 'city': 'Thunder Bay', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Northwestern Ontario Regional Cancer Centre, Thunder Bay', 'geoPoint': {'lat': 48.38202, 'lon': -89.25018}}, {'zip': 'M4C 3E7', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto East General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Sunnybrook Regional Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital - Toronto", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital - Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5S 1B6', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "Women's College Campus, Sunnybrook and Women's College Health Science Center", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M6R 1B5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "Saint Joseph's Health Centre - Toronto", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M9N 1N8', 'city': 'Weston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Humber River Regional Hospital', 'geoPoint': {'lat': 43.70359, 'lon': -79.51513}}, {'zip': 'N8W 2X3', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Cancer Care Ontario - Windsor Regional Cancer Centre', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'C1A 8T5', 'city': 'Charlottetown', 'state': 'Prince Edward Island', 'country': 'Canada', 'facility': 'Queen Elizabeth Hospital, PEI', 'geoPoint': {'lat': 46.23459, 'lon': -63.1256}}, {'zip': 'J1H 5N4', 'city': 'Fleurimont', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUS-Hopital Fleurimont', 'geoPoint': {'lat': 45.40842, 'lon': -71.83796}}, {'zip': 'J4V 2H1', 'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Charles Lemoyne', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'J6E 6J2', 'city': 'Joliette', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Regional de Lanaudiere', 'geoPoint': {'lat': 46.0164, 'lon': -73.4236}}, {'zip': '(P.Q.) H2X 3J4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre Hospitalier de l'Universite de Montreal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Maisonneuve-Rosemont Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2W 1S6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Sainte Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4J 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Du Sacre-Coeur de Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H9R 4S3', 'city': 'Pointe-Claire', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Kells Medical Research Group Inc.', 'geoPoint': {'lat': 45.44868, 'lon': -73.81669}}, {'zip': 'G1R 2J6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Quebec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'G1S 4L8', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital du Saint-Sacrament, Quebec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'G5L 5T1', 'city': 'Rimouski', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Regional de Rimouski', 'geoPoint': {'lat': 48.44879, 'lon': -68.52396}}, {'zip': 'G1V 4G5', 'city': 'Ste-Foy', 'state': 'Quebec', 'country': 'Canada', 'facility': "L'Hopital Laval"}, {'zip': 'S4T 7T1', 'city': 'Regina', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Allan Blair Cancer Centre', 'geoPoint': {'lat': 50.45008, 'lon': -104.6178}}, {'zip': 'S7N 4H4', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Saskatoon Cancer Centre', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}, {'zip': 'V7L 2P9', 'city': 'North Vancouver', 'country': 'Canada', 'facility': 'Lions Gate Hospital', 'geoPoint': {'lat': 49.31636, 'lon': -123.06934}}], 'overallOfficials': [{'name': 'Richard M. Goldberg, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alliance for Clinical Trials in Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'NCIC Clinical Trials Group', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}