Evaluation of RNA From the Liver Tissue Obtained in Patients With Chronic Hepatitis C (0000-123)

Evaluation of RNA Quality and the Reproducibility of Gene Expression Profiling From Liver Tissue Obtained by Fine Needle Aspiration in Patients With Chronic Hepatitis C.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00828269

Enrollment

Registered

2009-01-23

Start date

2009-04-30

Completion date

2010-03-31

Last updated

2015-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

Patients with Chronic Hepatitis C

Brief summary

The purpose of this study is to evaluate the quality of the RNA and the reproducibility of gene expression profiling from liver tissue samples obtained by fine needle aspiration.

Interventions

PROCEDUREComparator: Fine needle aspiration biopsy

Visit 1: Screening Visit 2 (7-14 days from screening): Core needle biopsy and fine needle aspiration biopsy - liver. Visit 3:(7 days from visit 2): Fine needle aspiration biopsy - liver. Visit 4: (14 days from Visit 3): follow-up visit

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Patient has chronic hepatitis C (Genotype 1) * Patient has the ability to avoid use of anticoagulants, nonsteroidal anti-inflammatory drugs and aspirin for at least 5 days before the liver biopsy

Exclusion criteria

* Patient has received any approved or investigational drugs for the treatment of hepatitis C in the six months before the liver biopsy * Patient has HIV or Hepatitis B virus * Patient has been diagnosed with liver cancer * Patient has evidence of cirrhosis on any previous liver biopsy * Patient has confirmed alcohol abuse in the last 12 months * Patient has participated in any investigational drug study within 90 days before the current study

Design outcomes

Primary

Measure	Time frame
To evaluate the probability that fine needle aspiration of the liver results in RNA suitable to conduct gene expression tests.	5 weeks

Secondary

Measure	Time frame
Comparison of qPCR and microarray signature from patients with no or minimal fibrosis to that from patients with moderate to advanced fibrosis.	5 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026