Association Between Hepatitis C Infection and Renal Cell Carcinoma

September 16, 2014 updated by: Humberto C. Gonzalez, Henry Ford Health System

Association Between Hepatitis C Infection and Renal Cell Carcinoma, a Case Control Study

The purpose of this study is to determine if there is an association between hepatitis C infection and kidney cancer. All patients who are diagnosed with kidney cancer and who will either have a biopsy or surgery will be offered to be tested for hepatitis C. The control group will be colon cancer patients. Both groups would be of recent diagnosis (6 months).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Renal cell carcinoma patients will be identified from the urology clinic and from the hospital wards.

Colorectal cancer patient will be identifed from the hospital wards, pathology reports and gastroenterology endoscopy suits.

Description

Inclusion Criteria:

  • Male and female patients 18 years or older in whom renal cell carcinoma is suspected and are scheduled for either biopsy or partial or total nephrectomy. Diagnosis within 6 months.
  • Male and female patients 18 years or older in whom colorectal cancer has been diagnosed within the last 6 months

Exclusion Criteria:

  • Patients who are unwilling to provide consent
  • Patients who decline to complete a questionnaire
  • Patient in who blood sample cannot be obtained
  • Diagnosis of renal cell carcinoma or colon cancer greater than 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Renal Cell Carcinoma patients
Newly diagnosed (within 6 months) renal cell carcinoma patients in who a biopsy or surgery will be performed
Other: Hepatitis C testing
Hepatitis C antibody, Hepatitis C RNA quantitative and for those who test positive Hepatitis C genotype
Colorectal cancer patients
Newly diagnosed (6 months) colon cancer patients
Other: Hepatitis C testing
Hepatitis C antibody, Hepatitis C RNA quantitative and for those who test positive Hepatitis C genotype

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of hepatitis C in renal cell carcinoma patients
Time Frame: 2 years
Determine the prevalence of hepatitis C infection in newly diagnosed renal cell carcinoma patients
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Collaborators

Schering-Plough

Investigators

  • Principal Investigator: Humberto C Gonzalez, MD, Henry Ford Hospital
  • Study Chair: Stuart C Gordon, MD, Henry Ford Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

July 28, 2011

First Submitted That Met QC Criteria

July 28, 2011

First Posted (Estimate)

July 29, 2011

Study Record Updates

Last Update Posted (Estimate)

September 17, 2014

Last Update Submitted That Met QC Criteria

September 16, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P08406

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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