Association Between Hepatitis C Infection and Renal Cell Carcinoma

NCT ID: NCT01405183

Last Updated: 2014-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Hepatitis C Renal Cell Carcinoma Colorectal Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Renal Cell Carcinoma patients

Newly diagnosed (within 6 months) renal cell carcinoma patients in who a biopsy or surgery will be performed

Hepatitis C testing

Intervention Type OTHER

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

Hepatitis C testing

Intervention Type OTHER

Hepatitis C antibody, Hepatitis C RNA quantitative and for those who test positive Hepatitis C genotype

Interventions

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Hepatitis C testing

Hepatitis C antibody, Hepatitis C RNA quantitative and for those who test positive Hepatitis C genotype

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schering-Plough

INDUSTRY

Sponsor Role collaborator

Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Humberto C. Gonzalez

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Humberto C Gonzalez, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Hospital

Stuart C Gordon, MD

Role: STUDY_CHAIR

Henry Ford Hospital

Locations

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Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20332260 (View on PubMed)

Other Identifiers

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P08406

Identifier Type: -

Identifier Source: org_study_id

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