Carcinoma, HepatocellularNCT00913757
A Study of Molecular and Genetic Factors for Liver Cancer in the Greater Baltimore Area
An observational study of Carcinoma, Hepatocellular and Liver Cirrhosis, Alcoholic, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Carcinoma, Hepatocellular, Liver Cirrhosis, Alcoholic, Hepatitis, Alcoholic
- How many people
- 1,871 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2009to 1 May 2020
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will include 400 primary HCC cases, 800 patients with chronic liver disease (high risk non-cancer cases) and a sample of 800 population-based controls. The HCC and high risk non-cancer cases will be recruited at two Baltimore hospitals, the Veterans Affairs Medical Center and the University of Maryland School of Medicine over a period of 13 - 15 years. Controls will be identified through a Department of Motor Vehicle database and match cases by age, gender, race and county of residency.
Who may be able to join
- 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
- Diagnosed with primary liver cancer (HCC) within the last two years
- Physician diagnosis based on AFP and ultrasound/imaging or Pathological diagnosis of primary liver cancer made at the local hospital pathology department
- Resides in Maryland or surrounding states
Show all 41Show fewer
- 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.)
- Age is greater than or equal to 18 years and less than or equal to 90 years
- 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
- Is not currently residing in an institution, such as a prison, nursing home, or shelter
- Is not a severely ill patient in the intensive care unit
- Is able to give informed consent
- Is physically and mentally capable of performing the interview
- Must understand English well enough to be interviewed
- Has never been interviewed as a control for this study
- Subject provides informed consent and signs form.
- ELIGIBITY CRITERIA HIGH RISK NON-CANCER CASES
- Has been diagnosed with chronic Hepatitis B or C, NASH or alcoholic liver disease with chronicity present at least for a 6 month period
- Resides in Maryland or surrounding states
- Has a residential working phone within his/her home
- Age greater than or equal to 18 years and less than or equal to 90 years
- 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
- Is not currently residing in an institution, such as a prison, nursing home, or shelter
- Is not a severely ill patient in the intensive care unit
- Is able to give informed consent
- Is physically and mentally capable of performing the interview
- Must understand English well enough to be interviewed
- Has never been interviewed as a control for this study
- Subject provides informed consent and signs form.
- 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
- Resides in Baltimore City, Anne Arundel, Baltimore, Caroline, Carroll, Cecil, Dorchester, Harford, Howard, Kent, Queen Anne s, Somerset, Talbot, Wicomica and Worchester County.
- Has a residential working phone within his/her home
- Age greater than or equal to 18 years and less than or equal 90 years
- Have never had radiation therapy or chemotherapy
- Is not currently residing in an institution, such as a prison, nursing home, or shelter
- Is physically and mentally capable of performing the interview
- Must understand English well enough to be interviewed
- Has never been interviewed as a control for the study
- Subject provides informed consent and signs form.
Who cannot join
- 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.
- 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 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.
- 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.
- 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.
- Population controls who are younger than 18 years or are institutionalized are excluded due to the need of matching with HCC cases and high-risk non-cancer cases.
- Population controls with prior cancer with the exception of non-melanomic skin cancer (squamous or basal cell).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland Medical Center
Baltimore, Maryland
Veterans Affairs Medical Center
Baltimore, Maryland
About this study
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.
Read more
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.
Read the detailed description
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 (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.
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 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.
DESIGN:
The study will include 400 primary HCC cases, 800 patients with chronic liver disease (high risk non-cancer cases) and a sample of 800 population-based controls. The HCC and high risk non-cancer cases will be recruited at two Baltimore hospitals, the Veterans Affairs Medical Center, and the University of Maryland School of Medicine over a period of 13-15 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.
- Conditions
- Carcinoma, Hepatocellular, Liver Cirrhosis, Alcoholic, Hepatitis, Alcoholic, Hepatitis, Chronic, Hepatitis, Viral, Human
- Keywords
- Hepatocellular Carcinoma, Liver Cancer, Chronic Liver Disease, Genome Wide Association Study, Gene Expression Profiling
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Cirrhosis, Alcoholic, Hepatitis, Alcoholic, Hepatitis, Chronic, Hepatitis, Viral, Human, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 400 patients with primary HCC (Hepatocellular carcinoma) | |
| Group 2 | 800 patients with chronic liver disease (high risk non-cancer cases) | |
| Group 3 | 800 population-based controls, identified through a OMV database that will match cases by age, gender, race, and county of residency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Large-scale molecular profiling study to identify HCC biomarkers for early diagnosis and prevention.
Identification of HCC biomarkers for early diagnosis and prevention.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study start1 Jul 2009
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 1,871 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Xin Wang, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913757
- Sponsor's protocol ID
- 999909149
- Other IDs
- 09-C-N149
- Status last verified
- May 2020
- First submitted
- 3 Jun 2009
- Last updated
- 4 May 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Molecular and Genetic Factors for Liver Cancer in the Greater Baltimore Area
- ClinicalTrials.gov ID
- NCT00913757
- Acronym / sponsor ID
- 999909149
- Conditions
- Carcinoma, Hepatocellular, Liver Cirrhosis, Alcoholic, Hepatitis, Alcoholic, Hepatitis, Chronic, Hepatitis, Viral, Human
- Keywords
- Hepatocellular Carcinoma, Liver Cancer, Chronic Liver Disease, Genome Wide Association Study, Gene Expression Profiling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,871 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 Jul 2009 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 4 Jun 2009 (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.
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.
Detailed description
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 (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.
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 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.
DESIGN:
The study will include 400 primary HCC cases, 800 patients with chronic liver disease (high risk non-cancer cases) and a sample of 800 population-based controls. The HCC and high risk non-cancer cases will be recruited at two Baltimore hospitals, the Veterans Affairs Medical Center, and the University of Maryland School of Medicine over a period of 13-15 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –400 patients with primary HCC (Hepatocellular carcinoma) |
| Group 2 | – | –800 patients with chronic liver disease (high risk non-cancer cases) |
| Group 3 | – | –800 population-based controls, identified through a OMV database that will match cases by age, gender, race, and county of residency |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include 400 primary HCC cases, 800 patients with chronic liver disease (high risk non-cancer cases) and a sample of 800 population-based controls. The HCC and high risk non-cancer cases will be recruited at two Baltimore hospitals, the Veterans Affairs Medical Center and the University of Maryland School of Medicine over a period of 13 - 15 years. Controls will be identified through a Department of Motor Vehicle database and match cases by age, gender, race and county of residency.
Key inclusion criteria (41 listed)
- 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
- Diagnosed with primary liver cancer (HCC) within the last two years
- Physician diagnosis based on AFP and ultrasound/imaging or Pathological diagnosis of primary liver cancer made at the local hospital pathology department
Key exclusion criteria (7 listed)
- 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.
- 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 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Large-scale molecular profiling study to identify HCC biomarkers for early diagnosis and prevention.
Time frame: ongoing
Identification of HCC biomarkers for early diagnosis and prevention.
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 4 May 2020.
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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.
Xin Wang, M.D. principal investigator
National Cancer Institute (NCI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Hepatocellular and Liver Cirrhosis, Alcoholic, run by National Cancer Institute (NCI) at 2 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 41 inclusion and 7 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 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Large-scale molecular profiling study to identify HCC biomarkers for early diagnosis and prevention. (time frame: ongoing). 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 4 May 2020.