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View Clinical Trial (Medical Research Study)
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A Study of Molecular and Genetic Factors for Liver Cancer in the Greater Baltimore Area - NCT00913757-20892 (Clinical Trial 296575)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy296575.aspx
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| City: |
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Bethesda |
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State:
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MD |
| Zip Code: |
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20892 |
| Conditions: |
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Carcinoma, Hepatocellular - Liver Cirrhosis, Alcoholic - Hepatitis, Alcoholic - Hepatitis, Chronic - Hepatitis, Viral, Human |
| Purpose: |
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Background:
- Liver cancer is the third most deadly and fifth most common cancer worldwide.
Hepatocellular carcinoma (HCC) is the most frequent primary liver cancer, and it has
grown more prevalent in the United States.
- More information is needed about the causes and effects of liver cancer, and further
research into individuals who are at high risk for developing liver cancer is needed
for early diagnosis and prevention.
Objectives:
- To identify genetic factors that may help to explain the aggressiveness of liver
cancer.
- To determine if HCC biomarkers exist in blood, urine, and tissue samples.
Eligibility:
- Patients between the ages of 18 and 90 who have been diagnosed with HCC or have a high
risk for developing HCC because of fatty liver disease (alcohol-related or
non-alcohol-related) or chronic hepatitis B or C.
- Participants will reside in Baltimore City and the surrounding areas.
Design:
- Participants will complete a questionnaire and provide blood and urine samples for
testing:
- The questionnaire will include questions about individual and family medical history,
tobacco use, and exposure to known factors for liver cancer.
- Blood and urine samples will be collected from all participants after the
questionnaire.
- Tumor tissue and healthy tissue will be collected from selected participants if they
undergo surgery for their cancer or disease.
- No specific treatment will be offered as part of this protocol, but participants have
the option to be treated under different protocols.
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| Study summary: |
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BACKGROUND:
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.
OBJECTIVES:
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, 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.
ELIGIBILITY:
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 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.
DESIGN:
The study will include 250 primary HCC cases, 500 patients with chronic liver disease (high
risk non-cancer cases) and a sample of 500 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 Medical Center and the Johns Hopkins University
Medical Center, 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 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. |
| Criteria: |
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- INCLUSION CRITERIA:
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
1. Diagnosed with primary liver cancer (HCC) within the last one year
2. Physician diagnosis based on AFP and ultrasound/imaging or Pathological diagnosis of
primary liver cancer made at the local hospital pathology department
3. Resides in Baltimore City or contiguous metropolitan counties, Anne Arundel counties,
and Eastern Shore
4. Has a residential working phone within his/her home (*The reason for a participant
having a residential working phone is that the matching population controls are
selected through the Department of Motor Vehicles records and must have a residential
telephone number to be selected as part of the random sample.)
5. Age is greater than or equal to 18 years and less than or equal to 90 years
6. A non-objection statement by the physician from the hospital where the patient was
identified, or listed as the treating physician by the tumor registry or surgical
pathology report, to contact the patient is obtained
7. Is not currently residing in an institution, such as a prison, nursing home, or
shelter
8. Is not a severely ill patient in the intensive care unit
9. Is able to give informed consent
10. Is physically and mentally capable of performing the interview
11. Must understand English well enough to be interviewed
12. Has never been interviewed as a control for this study
13. Subject provides informed consent and signs form.
ELIGIBITY CRITERIA- HIGH RISK NON-CANCER CASES
1. Has been diagnosed with chronic Hepatitis B or C, NASH or alcoholic liver disease
2. Resides in Baltimore City or contiguous metropolitan counties, Anne Arundel counties
and Eastern Shore
3. Has a residential working phone within his/her home
4. Age greater than or equal to 18 years and less than or equal to 90 years
5. A non-objection statement by the physician from the hospital where the patient was
identified or is being treated or by the surgical pathology report, to contact the
patient is obtained
6. Is not currently residing in an institution, such as a prison, nursing home, or
shelter
7. Is not a severely ill patient in the intensive care unit
8. Is able to give informed consent
9. Is physically and mentally capable of performing the interview
10. Must understand English well enough to be interviewed
11. Has never been interviewed as a control for this study
12. Subject provides informed consent and signs form.
SELECTION OF POPULATION-BASED CONTROLS
Population-based controls will be identified through the Department of Motor Vehicles
(DMV), and matched on age (year of birth), race and gender 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
1. Resides in Baltimore City or contiguous metropolitan counties, Anne Arundel counties
and Eastern Shore
2. Has a residential working phone within his/her home
3. Age greater than or equal to 18 years and less than or equal 90 years
4. Have never had radiation therapy or chemotherapy
5. Is not currently residing in an institution, such as a prison, nursing home, or
shelter
6. Is not currently residing in an institution, such as a prison, nursing home, or
shelter
7. Is physically and mentally capable of performing the interview
8. Must understand English well enough to be interviewed
9. Has never been interviewed as a control for the study
10. Subject provides informed consent and signs form.
EXCLUSION CRITERIA:
Exclusion Criteria-HCC CANCER CASES
1. Liver cancer patients who are older than 90 years are excluded because of
co-morbidity considerations and the difficulty of matching those cases with
population-based controls.
2. Children and institutionalized patients are excluded from the proposed study. Very
few HCC patients at the 3 participating hospitals are younger than 18 years of age
and HCC incidence mainly occurs in adults.
Exclusion Criteria-HCC HIGH-RISK NON-CANCER CASES
1. High Risk Non-Cancer patients who are older than 90 years are excluded because of
co-morbidity considerations and the difficulty of matching those cases with
population-based controls.
2. Children and institutionalized patients are excluded from the proposed study. Very
few HCC patients at the 3 participating hospitals are younger than 18 years of age
and HCC incidence mainly occurs in adults. High-Risk Non-Cancer cases who are younger
than 18 years are excluded due to the need of matching with HCC cases and population
controls.
Exclusion Criteria-POPULATION BASED CONTROLS
1. Population based controls who are older than 90 years are excluded because of
co-morbidity considerations and the difficulty of matching with HCC cases and high
risk non-cancer cases.
2. Population controls who are younger than 18 years and are institutionalized are
excluded due to the need of matching with HCC cases and high-risk non-cancer cases. |
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| Study is available at: |
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National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, MD 20892
United States
Primary Contact:
Xin Wei Wang, M.D.
Email: xw3u@nih.gov
Phone: (301) 496-2099 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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