Liver CancerNCT00482586
Quality of Life in Patients With Liver Cancer Treated With Image-Guided Therapy
An observational study of Liver Cancer and Metastatic Cancer, run by Vanderbilt University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Metastatic Cancer
- What is being tested?
- medical chart review, questionnaire administration and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 137 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2003to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: Outcomes Following Image-Guided Therapy for Hepatic Malignancies
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.
Read the 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
- Conditions
- Liver Cancer, Metastatic Cancer
- Being tested
- medical chart review, questionnaire administration, quality-of-life assessment
- Keywords
- adult primary liver cancer, liver metastases
- Medical subject headings
- Liver Neoplasms, Neoplasm Metastasis, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical chart reviewOther
Also called Ablation, Embolization
Review the medical charts of patients with hepatic neoplasms who undergo Image-guided Therapy.
questionnaire administrationOther
Also called Ablation, Embolization, Chemo-embolization
Patients with hepatic neoplasms who undergo Image-guided Therapy
quality-of-life assessmentProcedure or surgery
Also called Ablation, Embolization, Chemoembolization
Patients with hepatic neoplasms who undergo Image-guided Therapy
| Study group | Role | What they receive |
|---|---|---|
| Image-guided Therapy | Patients undergoing Image-guided Therapy of Hepatic Neoplasms. Receives: Other: medical chart review; Other: questionnaire administration; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2007 (estimated)
- Study startOct 2003
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Steven Meranze, Vanderbilt University
- Investigators
- Steven G. Meranze, MD, Study chair, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482586
- Sponsor's protocol ID
- CDR0000546520
- Other IDs
- P30CA068485, VU-VICC-GI-0372, VU-VICC-IRB-020874
- Status last verified
- Jun 2015
- First submitted
- 4 Jun 2007
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Following Image-Guided Therapy for Hepatic Malignancies
- ClinicalTrials.gov ID
- NCT00482586
- Acronym / sponsor ID
- CDR0000546520
- Conditions
- Liver Cancer, Metastatic Cancer
- Keywords
- adult primary liver cancer, liver metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2003
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 5 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Image-guided Therapy | – | Other: medical chart review, Other: questionnaire administration, Procedure: quality-of-life assessmentPatients undergoing Image-guided Therapy of Hepatic Neoplasms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hepatic neoplasms who undergo Image-guided Therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical chart reviewAlso: Ablation, EmbolizationReview the medical charts of patients with hepatic neoplasms who undergo Image-guided Therapy. | Other | Image-guided Therapy |
| questionnaire administrationAlso: Ablation, Embolization, Chemo-embolizationPatients with hepatic neoplasms who undergo Image-guided Therapy | Other | Image-guided Therapy |
| quality-of-life assessmentAlso: Ablation, Embolization, ChemoembolizationPatients with hepatic neoplasms who undergo Image-guided Therapy | Procedure or surgery | Image-guided Therapy |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven G. Meranze, MD study chair
Vanderbilt-Ingram Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer and Metastatic Cancer, run by Vanderbilt University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.