Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-07-19 @ 7:26 PM
Study NCT ID:
NCT00739167
Status:
COMPLETED
Last Update Posted:
2015-10-16
First Post:
2008-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life in Patients Undergoing Embolization Using Yttrium Y 90 Glass Microspheres for Primary or Metastatic Liver Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-14', 'studyFirstSubmitDate': '2008-08-20', 'studyFirstSubmitQcDate': '2008-08-20', 'lastUpdatePostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life of all patients over the course of treatment', 'timeFrame': 'Before treatment, 2 weeks post, and 1 month post'}, {'measure': 'Quality of life differences between treatment groups', 'timeFrame': 'Before treatment, 2 weeks post, and 1 month post'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adult primary hepatocellular carcinoma', 'advanced adult primary liver cancer', 'liver metastases', 'recurrent adult primary liver cancer'], 'conditions': ['Liver Cancer', 'Metastatic Cancer']}, 'referencesModule': {'references': [{'pmid': '23644386', 'type': 'DERIVED', 'citation': 'Salem R, Gilbertsen M, Butt Z, Memon K, Vouche M, Hickey R, Baker T, Abecassis MM, Atassi R, Riaz A, Cella D, Burns JL, Ganger D, Benson AB 3rd, Mulcahy MF, Kulik L, Lewandowski R. Increased quality of life among hepatocellular carcinoma patients treated with radioembolization, compared with chemoembolization. Clin Gastroenterol Hepatol. 2013 Oct;11(10):1358-1365.e1. doi: 10.1016/j.cgh.2013.04.028. Epub 2013 May 2.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Learning about quality of life in patients with cancer undergoing embolization may help doctors learn about the side effects of treatment and plan the best treatment.\n\nPURPOSE: This clinical trial is studying quality of life in patients undergoing embolization using yttrium Y 90 glass microspheres for primary or metastatic liver cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Assess the quality of life (QOL) as defined by the presence or absence of physical, social, emotional, and functional distress in patients with primary or metastatic liver cancer undergoing treatment with radioembolization or transcatheter arterial embolization.\n* Compare the time course of QOL measures between treatment groups in patients treated with these regimens.\n* Compare the time course of QOL measures between patient subgroups defined by pre-treatment quality of life or tumor burden.\n\nOUTLINE: Patients complete FACT-Hep version 4 surveys on quality of life prior to initiation of embolization, and at 2 weeks and 1 month after completion of embolization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a diagnosis of hepatocellular carcinoma being treated with either TACE, RFA, or Y90.', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of primary hepatocellular cancer or metastatic liver cancer\n* Planning radioembolization or transcatheter arterial embolization using yttrium Y 90 glass microspheres\n* No encephalopathy\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* Bilirubin ≤ 3 mg/dL\n* Able to comply with study procedures\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior treatment with radioembolization or transcatheter arterial embolization'}, 'identificationModule': {'nctId': 'NCT00739167', 'briefTitle': 'Quality of Life in Patients Undergoing Embolization Using Yttrium Y 90 Glass Microspheres for Primary or Metastatic Liver Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'A Quality of Life Study for Patients With Primary or Metastatic Liver Cancer Who Are Treated With Radioembolization (Y90 Microspheres) or Transcatheter Arterial Embolization (TACE)', 'orgStudyIdInfo': {'id': 'NU 07Q1'}, 'secondaryIdInfos': [{'id': 'P30CA060553', 'link': 'https://reporter.nih.gov/quickSearch/P30CA060553', 'type': 'NIH'}, {'id': 'NU-07Q1'}, {'id': 'NU-IRB-STU00002799'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Y90 Group', 'description': 'Patients receiving treatment with radioembolization.'}, {'label': 'TACE Group', 'description': 'Patients receiving treatment with transcatheter arterial embolization'}, {'label': 'RFA Group', 'description': 'Patients receiving treatment with radiofrequency ablation.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611-3013', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robert H. Lurie Comprehensive Cancer Center at Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Peggy Gilbertsen, RN, BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Robert H. Lurie Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}