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Association Between Hepatitis C Virus Infection and Hematologic and Thyroid Cancers

Primary Purpose

Hepatitis C Virus

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Hepatitis C Virus focused on measuring Lymphoma, Multiple Myeloma, Thyroiditis, Cohort Study, Record linkage study, Hepatitis C

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

None given.

Sites / Locations

  • Houston Veterans AFfairs Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 19, 2006
Last Updated
June 30, 2017
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00342641
Brief Title
Association Between Hepatitis C Virus Infection and Hematologic and Thyroid Cancers
Official Title
Associations of Hematologic Malignancies and Thyroid Cancer With HCV Infection Among US Military Veterans
Study Type
Observational

2. Study Status

Record Verification Date
December 13, 2011
Overall Recruitment Status
Completed
Study Start Date
June 8, 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 13, 2011 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus
Keywords
Lymphoma, Multiple Myeloma, Thyroiditis, Cohort Study, Record linkage study, Hepatitis C

7. Study Design

Enrollment
815000 (Anticipated)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
None given.
Facility Information:
Facility Name
Houston Veterans AFfairs Medical Center
City
Houston
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15619249
Citation
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.
Results Reference
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PubMed Identifier
15185346
Citation
Engels 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.
Results Reference
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PubMed Identifier
15185336
Citation
Negri 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.
Results Reference
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Association Between Hepatitis C Virus Infection and Hematologic and Thyroid Cancers

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