Risk Factors and Molecular Genomics of U.S. Patients With Chronic Liver Disease &Hepatocellular CA
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Purpose
To identify risk factors for the development and diagnosis of hepatocellular CA in patients with chronic hepatitis C and to use the data to ultimately develop an effective screening program.
| Condition |
|---|
|
Carcinoma, Hepatocellular |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Risk Factors and Molecular Genomics for Hepatolcellular Carcinoma in U.S. Patients With Chronic Liver Disease: A Case Control Study |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
For Experimental Subjects Only:
Patients with HCC
For Controls Only:
Patients with chronic liver disease without evidence of HCC
Inclusion Criteria:*For both experimental subjects and controls:
- Patients between older than 18 years of age of all ethnic backgrounds and genders.
- Patients with chronic liver disease
For Experimental Subjects Only:
1. Patients with HCC with either: (i) a hepatic mass larger or equal to 5cm, or; (ii) a hepatic mass lesion confirmed by fine needle aspirate (FNA) or by pathology in the cases of surgical resection, or; (iii) a hepatic mass lesion with characteristic CT or MRI or angiographic appearance.
For Controls Only:
Patients with chronic liver disease without evidence of HCC confirmed by either :
- a normal AFP level
- a negative imaging study (ultrasound, CT, or MR imaging).
- Negative liver cancer on explants.
Exclusion Criteria:1. Patients who declined to participate in the study 2. Patients with a history of HIV infection 3. Patients with concurrent advanced malignancy of non-hepatic origin. 4. Patients with significant use of androgenic steroid. 5. Patients with exposure to vinyl chloride.
Contacts and Locations| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| Principal Investigator: | Mindie H. Nguyen | Stanford University |
More Information
No publications provided
| Responsible Party: | Mindie H. Nguyen, Stanford University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01034865 History of Changes |
| Other Study ID Numbers: | SU-11022007-788, 76873, HEP0009 |
| Study First Received: | December 16, 2009 |
| Last Updated: | December 16, 2009 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Carcinoma Liver Diseases Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Digestive System Diseases Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site |
ClinicalTrials.gov processed this record on May 19, 2013