Association Between Hepatitis C Infection and Renal Cell Carcinoma

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01405183
• Other study ID #: P08406
• Status: Completed
• Phase: N/A
• First received: July 28, 2011
• Last updated: September 16, 2014
• Start date: January 2011
• Est. completion date: September 2013

Study information

• Verified date: September 2014
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Colorectal Cancer
• Colorectal Neoplasms
• Hepatitis
• Hepatitis A
• Hepatitis C
• Renal Cell Carcinoma

Intervention

Other:
• Hepatitis C testing
Hepatitis C antibody, Hepatitis C RNA quantitative and for those who test positive Hepatitis C genotype

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	Schering-Plough

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gordon SC, Moonka D, Brown KA, Rogers C, Huang MA, Bhatt N, Lamerato L. Risk for renal cell carcinoma in chronic hepatitis C infection. Cancer Epidemiol Biomarkers Prev. 2010 Apr;19(4):1066-73. doi: 10.1158/1055-9965.EPI-09-1275. Epub 2010 Mar 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of hepatitis C in renal cell carcinoma patients	Determine the prevalence of hepatitis C infection in newly diagnosed renal cell carcinoma patients	2 years	No