Quality of Life in Patients With Liver Cancer Treated With Image-Guided Therapy
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| First Received Date ICMJE | June 4, 2007 | ||||
| Last Updated Date | August 8, 2011 | ||||
| Start Date ICMJE | October 2003 | ||||
| Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00482586 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Quality of Life in Patients With Liver Cancer Treated With Image-Guided Therapy | ||||
| Official Title ICMJE | Outcomes Following Image-Guided Therapy for Hepatic Malignancies | ||||
| Brief Summary | RATIONALE: Gathering information about quality of life over time from patients with liver cancer treated with image-guided therapy may help the study of cancer in the future. PURPOSE: This clinical trial is gathering information about quality of life over time from patients with liver cancer treated with image-guided therapy. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a pilot, prospective, longitudinal study. Patients complete a standard questionnaire assessing health-related quality of life at baseline, during routine follow-up care after image-guided therapy, and then annually thereafter. Health and disease status and the development of other illnesses are assessed by medical record review. PROJECTED ACCRUAL: Not specified |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with hepatic neoplasms who undergo Image-guided Therapy |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Group/Cohort (s) | Image-guided Therapy
Patients undergoing Image-guided Therapy of Hepatic Neoplasms.
Interventions:
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00482586 | ||||
| Other Study ID Numbers ICMJE | CDR0000546520, P30CA068485, VU-VICC-GI-0372, VU-VICC-IRB-020874 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Steven G. Meranze, M.D., Vanderbilt University | ||||
| Study Sponsor ICMJE | Vanderbilt University | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | Vanderbilt University | ||||
| Verification Date | August 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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