Liver CancerNCT00482365
National Registry and Blood Bank of Patients With Liver Cancer
An observational study of Liver Cancer, run by Vanderbilt-Ingram Cancer Center at 3 sites in United States.
Trial summary
RATIONALE: Gathering health information about patients with liver cancer over time may help doctors learn more about the disease and may help the study of cancer in the future. PURPOSE: This clinical trial is developing a national registry and blood bank of patients with liver cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- biologic sample preservation procedure, medical chart review and Patient interview
- How many people
- 151 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2002to Aug 2009
- 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 identified as having Hepatocellular carcinoma (HCC).
Who may be able to join
- Diagnosis of hepatocellular carcinoma at a participating institution
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37067-1631
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37067
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: A National Registry of Patients With Hepatocellular Carcinoma
RATIONALE: Gathering health information about patients with liver cancer over time may help doctors learn more about the disease and may help the study of cancer in the future.
PURPOSE: This clinical trial is developing a national registry and blood bank of patients with liver cancer.
Read the detailed description
OBJECTIVES:
- Evaluate etiologic factors associated with hepatocellular carcinoma (HCC) in different ethnic groups and in different parts of the United States by developing a national registry of HCC patients.
- Survey stage and potential treatability of HCC patients referred to Vanderbilt University Hospital.
- Establish a serum repository for registry patients with samples to be used for future studies of the pathogenesis of chronic liver disease and HCC and for developing better diagnostic tests.
OUTLINE: This is a multicenter, cross-sectional database study.
Data are collected on patients diagnosed with hepatocellular carcinoma at Vanderbilt University Medical Center and at other participating hospitals or liver transplantation centers around the country for inclusion in a national registry of liver cancer patients. Registry data are collected at baseline and then every 6 months for up to 5 years. The data are derived from investigator interviews with patients and from medical chart review of routine medical care provided during the course of the study. Data are collected from all study sites and entered into a master database that includes information on patient demographics, diagnoses and staging details, treatment history, results of laboratory studies, and patient outcomes. Information derived from the registry is available to investigators at all study sites.
Patients in the registry also undergo blood collection at baseline. Blood samples are stored in a serum repository for evaluation in future studies related to liver disease, viral hepatitis, and liver cancer. A biological marker that may be analyzed is squamous cell carcinoma antigen immune complex (SCCA-IC).
PROJECTED ACCRUAL: A total of 1,500 patients will be accrued for the Vanderbilt University Medical Center study and up to 2,000 patients for the national study.
- Conditions
- Liver Cancer
- Being tested
- biologic sample preservation procedure, medical chart review, Patient interview
- Keywords
- adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized resectable adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biologic sample preservation procedureOther
Also called blood draw and storage
biologic sample preservation procedure
medical chart reviewOther
review of patients' medical records at study entry and every 6 months
Patient interviewOther
Elicit demographic data as well as information about personal habits such as drinking and smoking.
What is being measured
The primary outcome is the main question the study is designed to answer.
Etiologic factors associated with hepatocellular carcinoma in different ethnic groups across the US
A descriptive analysis will be done to describe the number of patients with HCC, their underlying etiology, correlation between etiology and demographic features and the outcome of various forms of therapy. Survival analysis will be done, comparing various forms of therapy while adjusting for stage of disease.
Measured: every 6 months up to 5 years
Secondary outcomes (1)
Serum repository for registry patients
blood samples will be drawn at the time of standard of care and stored.
Measured: At study entry
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 startApr 2002
- Primary completionApr 2009
- Study completionAug 2009
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 only
- Time perspective
- Cross-sectional
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunil K. Geevarghese, Vanderbilt-Ingram Cancer Center
- Investigators
- Sunil Geevarghese, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482365
- Sponsor's protocol ID
- VICC GI 0224
- Other IDs
- VU-VICC-GI-0224, VU-VICC-IRB-020116
- Status last verified
- May 2013
- First submitted
- 4 Jun 2007
- Last updated
- 19 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National Registry of Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00482365
- Acronym / sponsor ID
- VICC GI 0224
- Conditions
- Liver Cancer
- Keywords
- adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized resectable adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Study start
- Apr 2002
- Primary completion
- Apr 2009 (actual)
- Study completion
- Aug 2009 (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 health information about patients with liver cancer over time may help doctors learn more about the disease and may help the study of cancer in the future.
PURPOSE: This clinical trial is developing a national registry and blood bank of patients with liver cancer.
Detailed description
OBJECTIVES:
- Evaluate etiologic factors associated with hepatocellular carcinoma (HCC) in different ethnic groups and in different parts of the United States by developing a national registry of HCC patients.
- Survey stage and potential treatability of HCC patients referred to Vanderbilt University Hospital.
- Establish a serum repository for registry patients with samples to be used for future studies of the pathogenesis of chronic liver disease and HCC and for developing better diagnostic tests.
OUTLINE: This is a multicenter, cross-sectional database study.
Data are collected on patients diagnosed with hepatocellular carcinoma at Vanderbilt University Medical Center and at other participating hospitals or liver transplantation centers around the country for inclusion in a national registry of liver cancer patients. Registry data are collected at baseline and then every 6 months for up to 5 years. The data are derived from investigator interviews with patients and from medical chart review of routine medical care provided during the course of the study. Data are collected from all study sites and entered into a master database that includes information on patient demographics, diagnoses and staging details, treatment history, results of laboratory studies, and patient outcomes. Information derived from the registry is available to investigators at all study sites.
Patients in the registry also undergo blood collection at baseline. Blood samples are stored in a serum repository for evaluation in future studies related to liver disease, viral hepatitis, and liver cancer. A biological marker that may be analyzed is squamous cell carcinoma antigen immune complex (SCCA-IC).
PROJECTED ACCRUAL: A total of 1,500 patients will be accrued for the Vanderbilt University Medical Center study and up to 2,000 patients for the national study.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients identified as having Hepatocellular carcinoma (HCC).
Key inclusion criteria (1 listed)
- Diagnosis of hepatocellular carcinoma at a participating institution
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| biologic sample preservation procedureAlso: blood draw and storagebiologic sample preservation procedure | Other | – |
| medical chart reviewreview of patients' medical records at study entry and every 6 months | Other | – |
| Patient interviewElicit demographic data as well as information about personal habits such as drinking and smoking. | Other | – |
Primary outcome
Etiologic factors associated with hepatocellular carcinoma in different ethnic groups across the US
Time frame: every 6 months up to 5 years
A descriptive analysis will be done to describe the number of patients with HCC, their underlying etiology, correlation between etiology and demographic features and the outcome of various forms of therapy. Survival analysis will be done, comparing various forms of therapy while adjusting for stage of disease.
1 secondary outcome
Serum repository for registry patients
Time frame: At study entry
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 19 Aug 2013.
Related trials for Liver Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
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.
Sunil Geevarghese, MD principal investigator
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, run by Vanderbilt-Ingram Cancer Center 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 19 Aug 2013. 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?
Etiologic factors associated with hepatocellular carcinoma in different ethnic groups across the US (time frame: every 6 months up to 5 years). 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 19 Aug 2013.