Hepatitis CNCT01405183
Association Between Hepatitis C Infection and Renal Cell Carcinoma
An observational study of Hepatitis C and Renal Cell Carcinoma, run by Henry Ford Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Renal Cell Carcinoma, Colorectal Cancer
- What is being tested?
- Hepatitis C testing
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Hepatitis C Infection and Renal Cell Carcinoma, a Case Control Study
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).
- Conditions
- Hepatitis C, Renal Cell Carcinoma, Colorectal Cancer
- Being tested
- Hepatitis C testing
- Keywords
- Hepatitis C, Renal Cell Carcinoma, Colorectal Cancer
- Medical subject headings
- Hepatitis C, Carcinoma, Renal Cell, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis C testingOther
Hepatitis C antibody, Hepatitis C RNA quantitative and for those who test positive Hepatitis C genotype
| Study group | Role | What they receive |
|---|---|---|
| Renal Cell Carcinoma patients | Newly diagnosed (within 6 months) renal cell carcinoma patients in who a biopsy or surgery will be performed Receives: Other: Hepatitis C testing | |
| Colorectal cancer patients | Newly diagnosed (6 months) colon cancer patients Receives: Other: Hepatitis C testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of hepatitis C in renal cell carcinoma patients
Determine the prevalence of hepatitis C infection in newly diagnosed renal cell carcinoma patients
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Responsible party
- Principal investigator, Humberto C. Gonzalez, Henry Ford Health System
- Investigators
- Humberto C Gonzalez, MD, Principal investigator, Henry Ford HospitalStuart C Gordon, MD, Study chair, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405183
- Sponsor's protocol ID
- P08406
- Status last verified
- Sep 2014
- First submitted
- 28 Jul 2011
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20332260
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Hepatitis C Infection and Renal Cell Carcinoma, a Case Control Study
- ClinicalTrials.gov ID
- NCT01405183
- Acronym / sponsor ID
- P08406
- Conditions
- Hepatitis C, Renal Cell Carcinoma, Colorectal Cancer
- Keywords
- Hepatitis C, Renal Cell Carcinoma, Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- Jan 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 29 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal Cell Carcinoma patients | – | Other: Hepatitis C testingNewly diagnosed (within 6 months) renal cell carcinoma patients in who a biopsy or surgery will be performed |
| Colorectal cancer patients | – | Other: Hepatitis C testingNewly diagnosed (6 months) colon cancer patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatitis C testingHepatitis C antibody, Hepatitis C RNA quantitative and for those who test positive Hepatitis C genotype | Other | Colorectal cancer patients, Renal Cell Carcinoma patients |
Primary outcome
Prevalence of hepatitis C in renal cell carcinoma patients
Time frame: 2 years
Determine the prevalence of hepatitis C infection in newly diagnosed renal cell carcinoma patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
- Background: PubMed 20332260Gordon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Humberto C Gonzalez, MD principal investigator
Henry Ford Hospital
Stuart C Gordon, MD study chair
Henry Ford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C and Renal Cell Carcinoma, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of hepatitis C in renal cell carcinoma patients (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01405183, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2014.