S1204, Viral Screening in Newly Diagnosed Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Southwest Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01946516
First received: September 16, 2013
Last updated: August 20, 2014
Last verified: August 2014

September 16, 2013
August 20, 2014
August 2013
February 2016   (final data collection date for primary outcome measure)
Prevalence of viral infection [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01946516 on ClinicalTrials.gov Archive Site
  • Risk factor evaluation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.
  • Timing and type of treatment for cancer and virus. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Among patients with HIV, HBV, or HCV, evaluate timing and type of treatments received, both for the viral infections and the cancers.
  • Type and rage of Adverse Events among patients with viral infection. [ Time Frame: 2 ] [ Designated as safety issue: No ]
    Estimate type and rate of cancer-treatment related adverse events among persons with HIV, HBV, and/or HCV infection.
  • Cost-effectiveness of viral screening [ Time Frame: 3 year ] [ Designated as safety issue: No ]
    Estimate the cost-effectiveness of screening for HIV, HBV, and HCV.
Same as current
Create biorepository of stored serum for future research. [ Time Frame: 2 ] [ Designated as safety issue: No ]
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.
Same as current
 
S1204, Viral Screening in Newly Diagnosed Cancer Patients
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Specimen submission is optional.

Non-Probability Sample

Community and academic oncology clinics

Cancer
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3061
August 2016
February 2016   (final data collection date for primary outcome measure)

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.)
Both
18 Years and older
No
Contact: Patricia O'Kane, B.S. 210-614-8808 ext 1011 pokane@swog.org
Contact: Kimberly Kaberle, B.S. 210-614-8808 ext 1022 kkaberle@swog.org
United States
 
NCT01946516
S1204, NCI-2013-01631, U10CA032102
Yes
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Scott D. Ramsey, M.D. Fred Hutchinson Cancer Research Center
Southwest Oncology Group
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP