Risk Factors and Molecular Genomics of U.S. Patients With Chronic Liver Disease and Hepatocellular Cancer
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ClinicalTrials.gov Identifier: NCT01034865 |
Recruitment Status :
Completed
First Posted : December 18, 2009
Last Update Posted : May 1, 2017
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Condition or disease |
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Carcinoma, Hepatocellular |
Study Type : | Observational |
Actual Enrollment : | 750 participants |
Observational Model: | Case-Control |
Time Perspective: | Cross-Sectional |
Official Title: | Risk Factors and Molecular Genomics for Hepatocellular Carcinoma in U.S. Patients With Chronic Liver Disease: A Case Control Study |
Study Start Date : | May 2001 |
Actual Primary Completion Date : | June 2009 |
Actual Study Completion Date : | June 2009 |

Group/Cohort |
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HCC PTS
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.
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LD
Patients with chronic liver disease without evidence of HCC
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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:
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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
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For Experimental Subjects Only:
- Patients with HCC with a hepatic mass larger or equal to 5cm
- Patients with HCC with a hepatic mass lesion confirmed by fine needle aspirate (FNA) or by pathology in the cases of surgical resection
- Patients with HCC with 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 :
1. A normal AFP level
2. a negative imaging study (ultrasound, CT, or MR imaging).
3. Negative liver cancer on explants.
*Exclusion Criteria:
- Patients who declined to participate in the study
- Patients with a history of HIV infection
- Patients with concurrent advanced malignancy of non-hepatic origin.
- Patients with significant use of androgenic steroid.
- Patients with exposure to vinyl chloride.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034865
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | Mindie H. Nguyen | Stanford University |
Responsible Party: | Mindie H. Nguyen, Associate Professor of Medicine, Stanford University |
ClinicalTrials.gov Identifier: | NCT01034865 |
Other Study ID Numbers: |
SU-11022007-788 76873 HEP0009 ( Other Identifier: Stanford ) |
First Posted: | December 18, 2009 Key Record Dates |
Last Update Posted: | May 1, 2017 |
Last Verified: | April 2017 |
Carcinoma Carcinoma, Hepatocellular Liver Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Digestive System Diseases Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site |