A Study of Molecular and Genetic Factors for Liver Cancer in the Greater Baltimore Area
|First Received Date ICMJE||June 3, 2009|
|Last Updated Date||October 11, 2014|
|Start Date ICMJE||May 2009|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Large-scale molecular profiling study to identify HCC biomarkers forearly diagnosis and prevention. [ Time Frame: duration of study ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00913757 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|
|Brief Title ICMJE||A Study of Molecular and Genetic Factors for Liver Cancer in the Greater Baltimore Area|
|Official Title ICMJE||A Study of Molecular and Genetic Factors for Liver Cancer in the Greater Baltimore Area|
Liver cancer is the third most deadly and fifth most common cancer worldwide. Hepatocellular carcinoma (HCC) is the most frequent primary cancer of the liver with rising incidence in the United States. HCC patients have a dismal outcome and are an underserved cancer population. We are proposing a liver cancer case-control and case-case study to be conducted in Baltimore, Maryland.
Our research is aimed to identify genetic and genomic changes that might explain the aggressive nature of liver cancer. We will test the primary hypothesis that HCC biomarkers exist in blood products (or mouth wash), urine and/or tissues that can be used for early diagnosis and prevention. A unique study factor is the use of urine samples for biomarker identification. A secondary goal will be to examine whether certain genetic and genomic factors modify liver cancer susceptibility using candidate and genome wide association study approaches. Although other studies have investigated genetic susceptibility, large scale studies have not been conducted for liver cancer. Our study will also be valuable due to access to frozen tumor specimens from pre-therapy resection, whose collection is required for gene expression analysis. If certain genes are related to HCC risk and progression, this tissue resource will be used to further validate our findings with laboratory investigations. The proposed study is designed to be exploratory and hypothesis generating.
The participants will reside in Baltimore City and surrounding areas. Cases will have pathologically confirmed liver cancer or risk factors for HCC development. Risk factors include chronic liver disease due to hepatitis B and/or C viral infection, nonalcoholic steatohepatitis or alcoholic cirrhosis. The study will be supported by an epidemiological infrastructure developed by our University of Maryland School of Medicine resource contractor for ongoing lung and prostate cancer case-control studies. The enrollment of controls will begin concurrently with case accrual, and will continue for 5 years. Population-based controls will be recruited using a triple eligibility criterion, such that controls eligible for the lung/prostate study will be asked to complete a supplemental questionnaire for the liver study.
The study will include 250 primary HCC cases, 500 patients with chronic liver disease (high risk non-cancer cases) and a sample of 750 population-based controls. The HCC and high risk non-cancer cases will be recruited at three Baltimore hospitals, the Veterans Affairs Medical Center, the University of Maryland School of Medicine and the Johns Hopkins Medical Institute, over a period of 5 years. Controls will be identified through a Department of Motor Vehicle database and match cases by age, gender, race and county of residency. The study will involve administration of a questionnaire and collection of blood (or mouth wash) from all study subjects. Fresh-frozen tumor and tumor surrounding non-cancerous specimens will be obtained from approximately 20 percent of the cancer patients. The cases will receive one questionnaire. The first 12 months will constitute a pilot study, during which we will evaluate and refine recruitment procedures.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||1500|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
SELECTION OF CASE SUBJECTS (HCC AND HIGH RISK NON-CANCER CASES)
We will recruit incident cases of pathologically confirmed primary liver cancer or risk factors for liver cancer (patients with chronic liver disease due to hepatitis B and/or C viral infection, nonalcoholic steatohepatitis or alcoholic cirrhosis) at all stages of the disease that are age greater than or equal to 18 years or less than or equal to 90 years. Treatment can be surgery or therapy. The following check list will be used to verify eligibility of a case subject.
ELIGIBILITY CRITERIA- HCC CANCER CASES
ELIGIBITY CRITERIA HIGH RISK NON-CANCER CASES
SELECTION OF POPULATION-BASED CONTROLS
Population-based controls will be identified through the Motor Vehicle Administration (MVA), and matched on age (year of birth), race, gender and geography to cases. We sample controls in proportion to the population size of their county of residence. Recruitment of controls will start concurrently with case accrual, using the age, race and gender frequency distribution of cancer patients in previous years. The sampling frame is continually updated as we accrue information on the case distribution of age, race and gender. We will exclude controls that do not have a listed home phone number. The following check list will be used to verify eligibility of a control subject.
ELIGIBILITY CRITERIA - POPULATION-BASED CONTROLS
Exclusion Criteria-HCC CANCER CASES
Exclusion Criteria-HCC HIGH-RISK NON-CANCER CASES
Exclusion Criteria-POPULATION BASED CONTROLS
|Ages||18 Years to 90 Years|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00913757|
|Other Study ID Numbers ICMJE||999909149, 09-C-N149|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||September 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP