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Risk Factors and Molecular Genomics of U.S. Patients With Chronic Liver Disease and Hepatocellular Cancer
This study has been completed.
Sponsor:
Stanford University
Information provided by (Responsible Party):
Mindie H. Nguyen, Stanford University
ClinicalTrials.gov Identifier:
NCT01034865
First received: December 16, 2009
Last updated: April 27, 2017
Last verified: April 2017
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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 Hepatocellular Carcinoma in U.S. Patients With Chronic Liver Disease: A Case Control Study |
Resource links provided by NLM:
Further study details as provided by Mindie H. Nguyen, Stanford University:
Biospecimen Retention: Samples With DNA
blood
| Enrollment: | 750 |
| Study Start Date: | May 2001 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
|
LD
Patients with chronic liver disease without evidence of HCC
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
For Experimental Subjects Only:
Patients with HCC
For Controls Only:
Patients with chronic liver disease without evidence of HCC
Criteria
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:
- 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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034865
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034865
Locations
| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
Sponsors and Collaborators
Stanford University
Investigators
| Principal Investigator: | Mindie H. Nguyen | Stanford University |
More Information
| Responsible Party: | Mindie H. Nguyen, Associate Professor of Medicine, Stanford University |
| ClinicalTrials.gov Identifier: | NCT01034865 History of Changes |
| Other Study ID Numbers: |
SU-11022007-788 76873 HEP0009 ( Other Identifier: Stanford ) |
| Study First Received: | December 16, 2009 |
| Last Updated: | April 27, 2017 |
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 June 23, 2017