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Quality of Life in Patients With Liver Cancer Treated With Image-Guided Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00482586
Recruitment Status : Completed
First Posted : June 5, 2007
Last Update Posted : June 8, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Steven Meranze, Vanderbilt University

Study Description
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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.


Condition or disease Intervention/treatment
Liver Cancer Metastatic Cancer Other: medical chart review Other: questionnaire administration Procedure: quality-of-life assessment

Detailed Description:

OBJECTIVES:

  • Develop a data repository for clinical and health-related quality of life outcome measures in patients with hepatic malignancies treated with image-guided therapies.

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

Study Design
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Study Type : Observational
Actual Enrollment : 137 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Outcomes Following Image-Guided Therapy for Hepatic Malignancies
Study Start Date : October 2003
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
Image-guided Therapy
Patients undergoing Image-guided Therapy of Hepatic Neoplasms.
 Other: medical chart review
Review the medical charts of patients with hepatic neoplasms who undergo Image-guided Therapy.
Other Names:
  • Ablation
  • Embolization

Other: questionnaire administration
Patients with hepatic neoplasms who undergo Image-guided Therapy
Other Names:
  • Ablation
  • Embolization
  • Chemo-embolization

Procedure: quality-of-life assessment
Patients with hepatic neoplasms who undergo Image-guided Therapy
Other Names:
  • Ablation
  • Embolization
  • Chemoembolization


Outcome Measures
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Primary Outcome Measures :
  1. Development of a data repository for clinical outcome measures by conducting a medical record review at baseline, during routine follow-up after image-guided therapy, and then annually thereafter [ Time Frame: one year ]
  2. Development of a data repository for health-related quality of life outcome measures by administering the Medical Outcomes Study Short Form questionnaire at baseline, during routine follow-up after image-guided therapy, and then annually thereafter [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with hepatic neoplasms who undergo Image-guided Therapy
Criteria

DISEASE CHARACTERISTICS:

  • Undergoing concurrent image-guided therapy for hepatic malignancies using any of the following imaging techniques:

    • X-ray
    • Ultrasound
    • MRI
    • CT scan
    • Nuclear medicine imaging

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00482586


Locations
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United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt University
National Cancer Institute (NCI)
Investigators
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Study Chair: Steven G. Meranze, MD Vanderbilt-Ingram Cancer Center
More Information
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Responsible Party: Steven Meranze, Professor of Radiology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00482586    
Other Study ID Numbers: CDR0000546520
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-GI-0372 ( Other Identifier: Vanderbilt University )
VU-VICC-IRB-020874 ( Other Identifier: Vanderbilt University )
First Posted: June 5, 2007    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015
Keywords provided by Steven Meranze, Vanderbilt University:
adult primary liver cancer
liver metastases
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Liver Diseases