Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT01163305
Status:
COMPLETED
Last Update Posted:
2017-05-08
First Post:
2010-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PET-CT and Circulating Tumor Cells in Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'circulating tumor cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-03', 'studyFirstSubmitDate': '2010-06-24', 'studyFirstSubmitQcDate': '2010-07-14', 'lastUpdatePostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor metabolic response via FDG-PET at 4 weeks after chemotherapy', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '4 years'}, {'measure': 'Progression-free survival', 'timeFrame': '4 years'}, {'measure': 'serum carcinoembryonic antigen (CEA) level', 'timeFrame': '4 years'}, {'measure': 'Circulating tumor cells level changes at 4 weeks after chemotherapy', 'timeFrame': '2 years'}, {'measure': 'RECIST-based tumor response at 10 weeks after chemotherapy', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Identifying an early indicator of drug efficacy'], 'conditions': ['Colorectal Cancer', 'Metastasis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to identify an early indicator of drug efficacy in patients with advanced colorectal cancer - a prospective evaluation of circulating tumor cells, positron-emission tomography scan and RECIST criteria.', 'detailedDescription': "1. To determine if measuring both tumor metabolic response (via FDG-PET scan) \\& circulating tumor cells (CirTC) at 4 weeks after starting treatment, is a better predictor of clinical outcome than measuring either modality alone in patients with metastatic colorectal cancer (CRC) who are undergoing first-line oxaliplatin-based chemotherapy.\n2. To determine if a new method of assessing drug response (measuring tumor metabolic response via FDG-PET \\& CirTC at 4 weeks after starting treatment) better predicts clinical outcome than the conventional method (measuring radiological changes in tumor dimensions at 10 weeks after starting treatment via the 'Response Evaluation Criteria in Solid Tumors' - RECIST)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with metastatic colorectal cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Metastatic colorectal cancer patients not received prior drug treatment for metastatic CRC\n* Age \\>= 18 years\n* (ECOG) performance status of 0-2\n* Measurable tumor sites by RECIST criteria\n* Adequate bone marrow, renal \\& hepatic functions\n\nExclusion Criteria:\n\n* Patients with diabetes mellitus\n* presence of hyperglycemia\n* Pregnant or lactating patients'}, 'identificationModule': {'nctId': 'NCT01163305', 'briefTitle': 'PET-CT and Circulating Tumor Cells in Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Identifying an Early Indicator of Drug Efficacy in Patients With Advanced Colorectal Cancer - a Prospective Evaluation of Circulating Tumor Cells, Positron-emission Tomography Scan and RECIST Criteria', 'orgStudyIdInfo': {'id': 'COL016'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'metastatic colorectal cancer', 'interventionNames': ['Drug: Chemotherapy']}], 'interventions': [{'name': 'Chemotherapy', 'type': 'DRUG', 'description': 'The majority of patients offered either oxaliplatin or irinotecan-based chemotherapy', 'armGroupLabels': ['metastatic colorectal cancer']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Department of Clinical Oncology, Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Brigette Ma, MD, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Brigette Ma', 'investigatorFullName': 'CCTU', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}