Hepatitis C VirusNCT00342641
Association Between Hepatitis C Virus Infection and Hematologic and Thyroid Cancers
An observational study of Hepatitis C Virus, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This study will investigate the possible relationship between infection with hepatitis C virus (HCV) and the development of certain hematologic cancers (Non-Hodgkin's lymphoma, Hodgkin's lymphoma, chronic lymphocytic leukemia, multiple myeloma) and thyroid cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis C Virus
- How many people
- 815,000 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2005to 13 Dec 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- None given.
Trial locations and contacts
1 site in 1 country.
United States1 site
Houston Veterans AFfairs Medical Center
Houston, Texas
About this study
Official title: Associations of Hematologic Malignancies and Thyroid Cancer With HCV Infection Among US Military Veterans
This study will investigate the possible relationship between infection with hepatitis C virus (HCV) and the development of certain hematologic cancers (Non-Hodgkin's lymphoma, Hodgkin's lymphoma, chronic lymphocytic leukemia, multiple myeloma) and thyroid cancer. HCV causes chronic hepatitis, cirrhosis, and liver cancer. It is transmitted primarily through injection drug use and transfusion of infected blood. Studies have shown that HCV may also be linked to hematologic cancers and thyroid cancer.
This retrospective study will examine medical records from veterans with and without HCV infection who previously received treatment in the Veterans Administration medical system. Data collected on each subject will include the subject's race, sex, age and era of military service, presence of liver disease or thyroiditis at their baseline clinic visit, number of inpatient visits in the past 5 years and outpatient visits in the past year, and the presence of various specified cancers. The prevalence of cancer and other conditions among HCV-infected subjects and non-HCV infected subjects at baseline and the subsequent development of the cancers of interest in these two groups will be compared and analyzed for a possible causal relationship.
Read the detailed description
Hepatitis C virus (HCV) may be a cause of hematologic malignancies and thyroid cancer. HCV infection is common among U.S. military veterans receiving care in the Veterans Administration healthcare system. The investigators propose a retrospective cohort study using VA administrative databases. A cohort of approximately 147,000 HCV-infected veterans has been identified for the period 1997-2004. Likewise, a cohort of approximately 573,000 HCV-uninfected veterans has been identified for the same period. These subjects are being evaluated for the diagnosis of hematologic malignancies, thyroid cancer, and related medical conditions as recorded in VA databases. The comparison of the prevalence and incidence of these cancers in the two cohorts will provide a test of the hypothesis that HCV infection can cause these cancers.
The investigators will also evaluate the association between HCV infection and several other medical conditions, which might be related to HCV infection, specifically: immune thrombocytopenic purpura, autoimmune hemolytic anemia, cholangiocarcinoma, cholangitis, and pancreatic cancer.
- Conditions
- Hepatitis C Virus
- Keywords
- Lymphoma, Multiple Myeloma, Thyroiditis, Cohort Study, Record linkage study, Hepatitis C
- Medical subject headings
- Hepatitis C, Lymphoma, Multiple Myeloma, Thyroiditis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start8 Jun 2005
- Study completion13 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C VirusStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Enrolment
- 815,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00342641
- Sponsor's protocol ID
- 999905172
- Other IDs
- 05-C-N172
- Status last verified
- 13 Dec 2011
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Dominitz JA, Boyko EJ, Koepsell TD, Heagerty PJ, Maynard C, Sporleder JL, Stenhouse A, Kling MA, Hrushesky W, Zeilman C, Sontag S, Shah N, Ona F, Anand B, Subik M, Imperiale TF, Nakhle S, Ho SB, Bini EJ, Lockhart B, Ahmad J, Sasaki A, van der Linden B, Toro D, Martinez-Souss J, Huilgol V, Eisen S, Young KA. Elevated prevalence of hepatitis C infection in users of United States veterans medical centers. Hepatology. 2005 Jan;41(1):88-96. doi: 10.1002/hep.20502.
PubMed 15619249Engels EA, Chatterjee N, Cerhan JR, Davis S, Cozen W, Severson RK, Whitby D, Colt JS, Hartge P. Hepatitis C virus infection and non-Hodgkin lymphoma: results of the NCI-SEER multi-center case-control study. Int J Cancer. 2004 Aug 10;111(1):76-80. doi: 10.1002/ijc.20021.
PubMed 15185346Negri E, Little D, Boiocchi M, La Vecchia C, Franceschi S. B-cell non-Hodgkin's lymphoma and hepatitis C virus infection: a systematic review. Int J Cancer. 2004 Aug 10;111(1):1-8. doi: 10.1002/ijc.20205.
PubMed 15185336
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations of Hematologic Malignancies and Thyroid Cancer With HCV Infection Among US Military Veterans
- ClinicalTrials.gov ID
- NCT00342641
- Acronym / sponsor ID
- 999905172
- Conditions
- Hepatitis C Virus
- Keywords
- Lymphoma, Multiple Myeloma, Thyroiditis, Cohort Study, Record linkage study, Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 815,000 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 8 Jun 2005
- Study completion
- 13 Dec 2011
- First posted
- 21 Jun 2006 (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.
This study will investigate the possible relationship between infection with hepatitis C virus (HCV) and the development of certain hematologic cancers (Non-Hodgkin's lymphoma, Hodgkin's lymphoma, chronic lymphocytic leukemia, multiple myeloma) and thyroid cancer. HCV causes chronic hepatitis, cirrhosis, and liver cancer. It is transmitted primarily through injection drug use and transfusion of infected blood. Studies have shown that HCV may also be linked to hematologic cancers and thyroid cancer.
This retrospective study will examine medical records from veterans with and without HCV infection who previously received treatment in the Veterans Administration medical system. Data collected on each subject will include the subject's race, sex, age and era of military service, presence of liver disease or thyroiditis at their baseline clinic visit, number of inpatient visits in the past 5 years and outpatient visits in the past year, and the presence of various specified cancers. The prevalence of cancer and other conditions among HCV-infected subjects and non-HCV infected subjects at baseline and the subsequent development of the cancers of interest in these two groups will be compared and analyzed for a possible causal relationship.
Detailed description
Hepatitis C virus (HCV) may be a cause of hematologic malignancies and thyroid cancer. HCV infection is common among U.S. military veterans receiving care in the Veterans Administration healthcare system. The investigators propose a retrospective cohort study using VA administrative databases. A cohort of approximately 147,000 HCV-infected veterans has been identified for the period 1997-2004. Likewise, a cohort of approximately 573,000 HCV-uninfected veterans has been identified for the same period. These subjects are being evaluated for the diagnosis of hematologic malignancies, thyroid cancer, and related medical conditions as recorded in VA databases. The comparison of the prevalence and incidence of these cancers in the two cohorts will provide a test of the hypothesis that HCV infection can cause these cancers.
The investigators will also evaluate the association between HCV infection and several other medical conditions, which might be related to HCV infection, specifically: immune thrombocytopenic purpura, autoimmune hemolytic anemia, cholangiocarcinoma, cholangitis, and pancreatic cancer.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 15619249Dominitz JA, Boyko EJ, Koepsell TD, Heagerty PJ, Maynard C, Sporleder JL, Stenhouse A, Kling MA, Hrushesky W, Zeilman C, Sontag S, Shah N, Ona F, Anand B, Subik M, Imperiale TF, Nakhle S, Ho SB, Bini EJ, Lockhart B, Ahmad J, Sasaki A, van der Linden B, Toro D, Martinez-Souss J, Huilgol V, Eisen S, Young KA. Elevated prevalence of hepatitis C infection in users of United States veterans medical centers. Hepatology. 2005 Jan;41(1):88-96. doi: 10.1002/hep.20502.
- Background: PubMed 15185346Engels EA, Chatterjee N, Cerhan JR, Davis S, Cozen W, Severson RK, Whitby D, Colt JS, Hartge P. Hepatitis C virus infection and non-Hodgkin lymphoma: results of the NCI-SEER multi-center case-control study. Int J Cancer. 2004 Aug 10;111(1):76-80. doi: 10.1002/ijc.20021.
- Background: PubMed 15185336Negri E, Little D, Boiocchi M, La Vecchia C, Franceschi S. B-cell non-Hodgkin's lymphoma and hepatitis C virus infection: a systematic review. Int J Cancer. 2004 Aug 10;111(1):1-8. doi: 10.1002/ijc.20205.
Related trials for Hepatitis C Virus
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Virus, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00342641, which also lists 3 linked publications.
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 2 Jul 2017.