Association Between Hepatitis C Infection and Renal Cell Carcinoma

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Humberto C. Gonzalez, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01405183
First received: July 28, 2011
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

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).


Condition Intervention
Hepatitis C
Renal Cell Carcinoma
Colorectal Cancer
Other: Hepatitis C testing

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Association Between Hepatitis C Infection and Renal Cell Carcinoma, a Case Control Study

Resource links provided by NLM:


Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • Prevalence of hepatitis C in renal cell carcinoma patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Determine the prevalence of hepatitis C infection in newly diagnosed renal cell carcinoma patients


Biospecimen Retention:   Samples Without DNA

Hepatits C antibody Hepatitis C RNA quantitative Hepatitis C Genotype


Enrollment: 240
Study Start Date: January 2011
Study Completion Date: September 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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: NCT01405183

Locations
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Schering-Plough
Investigators
Principal Investigator: Humberto C Gonzalez, MD Henry Ford Hospital
Study Chair: Stuart C Gordon, MD Henry Ford Hospital
  More Information

Publications:
Responsible Party: Humberto C. Gonzalez, MD, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01405183     History of Changes
Other Study ID Numbers: P08406
Study First Received: July 28, 2011
Last Updated: September 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Henry Ford Health System:
Hepatitis C
Renal Cell Carcinoma
Colorectal Cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Colorectal Neoplasms
Hepatitis
Hepatitis A
Hepatitis C
Adenocarcinoma
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Enterovirus Infections
Flaviviridae Infections
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Hepatitis, Viral, Human
Intestinal Diseases
Intestinal Neoplasms
Kidney Diseases
Kidney Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Picornaviridae Infections
Rectal Diseases
RNA Virus Infections
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014