NCT01405183

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

September 17, 2014

Status Verified

September 1, 2014

Enrollment Period

2.6 years

First QC Date

July 28, 2011

Last Update Submit

September 16, 2014

Conditions

Hepatitis CRenal Cell CarcinomaColorectal Cancer

Keywords

Hepatitis CRenal Cell CarcinomaColorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Colorectal cancer patients

Newly diagnosed (6 months) colon cancer patients

Other: Hepatitis C testing

Interventions

Hepatitis C testingOTHER

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

Colorectal cancer patientsRenal Cell Carcinoma patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related 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.

    PMID: 20332260BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Hepatits C antibody Hepatitis C RNA quantitative Hepatitis C Genotype

MeSH Terms

Conditions

Hepatitis CCarcinoma, Renal CellColorectal Neoplasms

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Humberto C Gonzalez, MD

    Henry Ford Hospital

    PRINCIPAL INVESTIGATOR

  • Stuart C Gordon, MD

    Henry Ford Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 28, 2011

First Posted

July 29, 2011

Study Start

January 1, 2011

Primary Completion

August 1, 2013

Study Completion

September 1, 2013

Last Updated

September 17, 2014

Record last verified: 2014-09

Locations

US(1)