Association Between Hepatitis C Infection and Renal Cell Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Henry Ford Health System.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01405183
First received: July 28, 2011
Last updated: August 12, 2011
Last verified: June 2011
  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


Estimated Enrollment: 278
Study Start Date: January 2011
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 Recruiting
Detroit, Michigan, United States, 48202
Contact: Humberto C Gonzalez, MD    313-916-2424    hgonzal1@hfhs.org   
Contact: Margaret French, RN    313-916-3369    mfrench1@hfhs.org   
Principal Investigator: Humberto C Gonzalez, MD         
Sub-Investigator: Stuart C Gordon, MD         
Sub-Investigator: Craig Rogers, MD         
Sub-Investigator: Lois Lamerato, PhD         
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, Gastroenterology Fellow
ClinicalTrials.gov Identifier: NCT01405183     History of Changes
Other Study ID Numbers: P08406
Study First Received: July 28, 2011
Last Updated: August 12, 2011
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
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Liver Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on August 27, 2014