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S1204, Viral Screening in Newly Diagnosed Cancer Patients

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ClinicalTrials.gov Identifier: NCT01946516
Recruitment Status : Active, not recruiting
First Posted : September 19, 2013
Last Update Posted : February 14, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Description
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Brief Summary:
The goal of this study is to estimate the prevalence of HIV, Hepatitis B and hepatitis C infection among newly diagnosed cancer patients presenting to community and academic oncology clinics.

Condition or disease
Cancer

Detailed Description:

Primary Objective

Among newly diagnosed cancer patients presenting to SWOG-affiliated community and academic oncology clinics, estimate the prevalence of human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection. Prevalence estimates will be further stratified: by whether infection with the virus(es) is known, as reported by patients and/or their physician prior to study testing, vs. unknown; by presenting cancer type, and by self-reported risk factors for each virus.

Secondary Objectives

  • Evaluate known sociodemographic, clinical, and behavioral factors that are significantly associated with previously undiagnosed HIV, HBV, and/or HCV infection in a population of people with newly diagnosed cancer.
  • Among patients who are identified as having HIV, HBV, and/or HCV, evaluate the timing and type of treatments received, both for the viral infections and the cancers.
  • Evaluate type and rate of cancer treatment-related adverse events in patients with HIV, HBV, and/or HCV infection.
  • Using simulation modeling that is directly informed by the data obtained from this study, determine the cost-effectiveness (expressed as cost per infection detected and cost per year of life gained) of (1) routine, universal screening and (2) risk factor-directed screening of newly diagnosed cancer patients for HIV, HBV, and/or HCV vs. current care.

Tertiary Objective

Create a biorepository of stored serum for future translational medicine studies that may include identifying genomic and viral factors that increase the risk of serious adverse effects among participants infected with HIV, HBV, and/or HCV being treated for invasive cancers.


Study Design
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Study Type : Observational
Actual Enrollment : 2863 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Sero-Epidemiologic Survey and Cost Effectiveness Study of Screening for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) Among Newly Diagnosed Cancer Patients
Actual Study Start Date : August 29, 2013
Actual Primary Completion Date : January 2018
Estimated Study Completion Date : February 2021
Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Prevalence of viral infection [ Time Frame: 2 years ]
    Among newly diagnosed cancer patients presenting to SWOG-affiliated community and academic oncology clinics, estimate the prevalence of human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection. Prevalence estimates will be further stratified: by whether infection with the virus(es) is known, as reported by patients and/or their physician prior to study testing, vs. unknown; by presenting cancer type, and by self-reported risk factors for each virus.


Secondary Outcome Measures :
  1. Risk factor evaluation [ Time Frame: 2 years ]
    Risk factors will be evaluated comparing all infections (within virus), known infections, and undiagnosed infections. Moreover, risk factors will be evaluated within tumor type, although our ability to make inferences within tumor types will be limited by relatively small numbers.

  2. Timing and type of treatment for cancer and virus. [ Time Frame: 2 years ]
    Among patients with HIV, HBV, or HCV, evaluate timing and type of treatments received, both for the viral infections and the cancers.

  3. Type and rage of Adverse Events among patients with viral infection. [ Time Frame: 2 ]
    Estimate type and rate of cancer-treatment related adverse events among persons with HIV, HBV, and/or HCV infection.

  4. Cost-effectiveness of viral screening [ Time Frame: 3 year ]
    Estimate the cost-effectiveness of screening for HIV, HBV, and HCV.


Other Outcome Measures:
  1. Create biorepository of stored serum for future research. [ Time Frame: 2 ]
    Create a biorepository of stored serum for the purposes of identifying genomic and viral factors that increase the risk of serious adverse effects among HIV, HBV and HCV infected persons being treated for cancer.


Biospecimen Retention:   Samples With DNA
Specimen submission is optional.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community and academic oncology clinics
Criteria

Inclusion Criteria:

  • presenting for evaluation or treatment of a new cancer malignancy(including hematologic)
  • confirmed pathologic diagnosis must be within 120 days of registration (Patients presenting for "second opinions" of confirmed malignancies are eligible, including those who have started cancer treatment at other facilities)
  • at least 18 years of age
  • patient must have had their blood drawn for HIV, HBV and HCV testing prior to registration (Patients who have had HIV, HBV and/or HCV testing within 60 days prior to registration and who do not wish to be retested are eligible, provided supporting documents can be obtained confirming viral test results for all three viruses. Documentation must be obtained prior to registration.

Patients who are viral positive for either HIV, HBV, and/or HCV and who do not wish to be retested are eligible, provided documentation of viral load within 120 days prior to registration can be obtained. Note that these patients must be tested for or provide current viral load for all three viruses to be eligible. Documentation must be obtained prior to registration.)

  • Patients must sign and give written informed consent in accordance with institutional and federal guidelines
  • Patients must be offered the opportunity to allow their blood specimens to be banked by the SWOG Repository for future research

Exclusion Criteria:

  • diagnosed with a malignancy other than the current malignancy within the past five years (with the exception of basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ breast cancer.)
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946516


  Show 58 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Scott D. Ramsey, M.D. Fred Hutchinson Cancer Research Center
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01946516     History of Changes
Other Study ID Numbers: S1204
NCI-2013-01631 ( Other Identifier: NCI )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: September 19, 2013    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018

Keywords provided by Southwest Oncology Group:
viral screening