Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2025-12-26 @ 3:27 AM
Study NCT ID:
NCT00442520
Status:
COMPLETED
Last Update Posted:
2016-11-28
First Post:
2007-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacogenomic Study in Patients of Lung, Colorectal and Head/Neck Cancers Receiving Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-23', 'studyFirstSubmitDate': '2007-03-01', 'studyFirstSubmitQcDate': '2007-03-01', 'lastUpdatePostDateStruct': {'date': '2016-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Lung Cancer', 'Colorectal Cancer', 'Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to look at several genes that might determine how the body processes the drugs used to treat lung, colorectal and head and neck cancers. The goal of this examination is to help investigators determine the proper dosage to give future cancer patients or to better predict which future patients will respond to particular drug therapies.', 'detailedDescription': "This study is to establish a pilot pharmacogenomic program in identifying genetic variation to predict the safety, toxicity and/or efficacy of drugs. DNA will be extracted from patients' peripheral blood to study SNPs in DPD, TS, MTHFR, UGT1A1, CYP3A4, CYP3A5, GSTM1, GSTT1, GSTP1, HO-1, ERCC1, XPD, XRCC1 and EGFR genes. The results of genetic study will be compared to treatment efficacy and toxicity. The ultimate goal is to use genotype profiles to provide individualized cancer treatment to improve outcome and decrease toxicity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'medical center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lung, Colorectal and Head and Neck Cancer Patients that have received or plan to receive chemotherapy as part of their treatment\n\nExclusion Criteria:\n\n* Colorectal cancer patients that have never received or will not receive chemotherapy as part of their therapy\n* Head and Neck cancer patients that have never received or will not receive chemotherapy as part of their treatment\n* Patients with cancer types other than colorectal or head and neck\n* Unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT00442520', 'briefTitle': 'Pharmacogenomic Study in Patients of Lung, Colorectal and Head/Neck Cancers Receiving Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Pharmacogenomic Study in Patients of Lung, Colorectal and Head/Neck Cancers Receiving Chemotherapy', 'orgStudyIdInfo': {'id': '10270'}}, 'armsInterventionsModule': {'armGroups': [{'label': '2', 'description': 'colorectal cancer patients'}, {'label': '3', 'description': 'head and neck cancer patients'}, {'label': '1', 'description': 'lung cancer patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Yu-Jui Yvonne Wan, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Paul J. Patton Trust', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}