Clinical trial · Observational
A Study of Molecular and Genetic Factors for Liver Cancer in the Greater Baltimore Area
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatitis, Alcoholic | — | UNRESOLVED | — |
| Hepatitis, Chronic | — | UNRESOLVED | — |
| Hepatitis, Viral, Human | — | UNRESOLVED | — |
| Liver Cirrhosis, Alcoholic | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Group 1
- description
- 400 patients with primary HCC (Hepatocellular carcinoma)
- label
- Group 2
- description
- 800 patients with chronic liver disease (high risk non-cancer cases)
- label
- Group 3
- description
- 800 population-based controls, identified through a OMV database that will match cases by age, gender, race, and county of residency
Primary outcomes (1)
- measure
- Large-scale molecular profiling study to identify HCC biomarkers for early diagnosis and prevention.
- timeFrame
- ongoing
- description
- Identification of HCC biomarkers for early diagnosis and prevention.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
* 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 two years 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 Maryland or surrounding states 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 with chronicity present at least for a 6 month period 2. Resides in Maryland or surrounding states 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 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 1. Resides in Baltimore City, Anne Arundel, Baltimore, Caroline, Carroll, Cecil, Dorchester, Harford, Howard, Kent, Queen Anne s, Somerset, Talbot, Wicomica and Worchester County. 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 physically and mentally capable of performing the interview 7. Must understand English well enough to be interviewed 8. Has never been interviewed as a control for the study 9. 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 or are institutionalized are excluded due to the need of matching with HCC cases and high-risk non-cancer cases. 3. Population controls with prior cancer with the exception of non-melanomic skin cancer (squamous or basal cell).
References
Publications (0)
Data not yet available