NCT00482586

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2003

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2007

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

11.5 years

First QC Date

June 4, 2007

Last Update Submit

June 3, 2015

Conditions

Liver CancerMetastatic Cancer

Keywords

adult primary liver cancerliver metastases

Outcome Measures

Primary Outcomes (2)

  • 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

    one year

  • 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

    one year

Study Arms (1)

Image-guided Therapy

Patients undergoing Image-guided Therapy of Hepatic Neoplasms.

Other: medical chart reviewOther: questionnaire administrationProcedure: quality-of-life assessment

Interventions

medical chart reviewOTHER

Review the medical charts of patients with hepatic neoplasms who undergo Image-guided Therapy.

Also known as: Ablation, Embolization
Image-guided Therapy
questionnaire administrationOTHER

Patients with hepatic neoplasms who undergo Image-guided Therapy

Also known as: Ablation, Embolization, Chemo-embolization
Image-guided Therapy
quality-of-life assessmentPROCEDURE

Patients with hepatic neoplasms who undergo Image-guided Therapy

Also known as: Ablation, Embolization, Chemoembolization
Image-guided Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with hepatic neoplasms who undergo Image-guided Therapy

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Liver NeoplasmsNeoplasm MetastasisCarcinoma, Hepatocellular

Interventions

Embolization, TherapeuticChemoembolization, Therapeutic

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Hemostatic TechniquesTherapeuticsTherapeutic Occlusion

Study Officials

  • Steven G. Meranze, MD

    Vanderbilt-Ingram Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Radiology

Study Record Dates

First Submitted

June 4, 2007

First Posted

June 5, 2007

Study Start

October 1, 2003

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

US(3)