Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-02-22 @ 7:42 AM
Study NCT ID:
NCT02107105
Status:
SUSPENDED
Last Update Posted:
2025-10-31
First Post:
2014-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 430}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'PI requested', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2014-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2030-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-29', 'studyFirstSubmitDate': '2014-04-04', 'studyFirstSubmitQcDate': '2014-04-07', 'lastUpdatePostDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health state utilities', 'timeFrame': 'At 24 months post-surgery', 'description': 'A health state utility is the degree of preference that individuals or society has for a particular health state or condition.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectal Adenocarcinoma', 'Stage I Rectal Cancer AJCC v8', 'Stage II Rectal Cancer AJCC v8', 'Stage IIA Rectal Cancer AJCC v8', 'Stage IIB Rectal Cancer AJCC v8', 'Stage IIC Rectal Cancer AJCC v8', 'Stage III Rectal Cancer AJCC v8', 'Stage IIIA Rectal Cancer AJCC v8', 'Stage IIIB Rectal Cancer AJCC v8', 'Stage IIIC Rectal Cancer AJCC v8', 'Stage IV Rectal Cancer AJCC v8', 'Stage IVA Rectal Cancer AJCC v8', 'Stage IVB Rectal Cancer AJCC v8', 'Stage IVC Rectal Cancer AJCC v8']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates quality of life and utilities following surgical treatment of stage I-IV rectal cancer. This study may help researches learn more about quality of life in patients who have or have had rectal cancer.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To assess post-treatment related health state utilities among patients with rectal cancer after treatment at 2 years.\n\nSECONDARY OBJECTIVES:\n\nI. To longitudinally compare the effects of treatment on quality of life and utilities among patients treated with or without (neo)adjuvant radiation therapy.\n\nII. To characterize the impact of treatment on quality of life and utilities among patients with rectal cancer.\n\nIII. To assess changes in quality of life and utilities among patients treated for rectal cancer over time.\n\nOUTLINE:\n\nPatients complete quality of life questionnaires over 20-30 minutes at baseline, 6 and 12 months after surgery, and 2, 3, 4, and 5 years after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with stave I-IV rectal adenocarcinoma at the Colorectal Clinic at M D Anderson Cancer Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has histologically proven adenocarcinoma of the rectum (stage I - IV) that is planned to be treated by surgical resection performed with curative intent, or who has already received surgical treatment\n* Patient must sign an approved informed consent document and have the literary and physical ability to complete the questionnaire in English\n\nExclusion Criteria:\n\n* Patient has been treated with pelvic radiation therapy for a diagnosis other than rectal cancer\n* Patient has a concurrent cancer diagnosis at the time of consent\n* Patient has recurrent disease'}, 'identificationModule': {'nctId': 'NCT02107105', 'briefTitle': 'Evaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Prospective Evaluation of Quality of Life and Utilities Following Surgical Treatment of Rectal Cancer', 'orgStudyIdInfo': {'id': '2013-0631'}, 'secondaryIdInfos': [{'id': 'NCI-2020-07835', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2013-0631', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}, {'id': 'K07CA133187', 'link': 'https://reporter.nih.gov/quickSearch/K07CA133187', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational (questionnaire)', 'description': 'Patients complete quality of life questionnaires over 20-30 minutes at baseline, 6 and 12 months after surgery, and 2, 3, 4, and 5 years after surgery.', 'interventionNames': ['Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Complete quality of life questionnaire', 'armGroupLabels': ['Observational (questionnaire)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Complete quality of life questionnaire', 'armGroupLabels': ['Observational (questionnaire)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'George J Chang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}