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
  Purpose

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
Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

Specimen submission is optional.


Estimated Enrollment: 3061
Study Start Date: August 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01946516

Contacts
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

Locations
United States, Hawaii
Tripler Army Medical Center Recruiting
Honolulu, Hawaii, United States, 96859
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
United States, Idaho
Saint Luke's Mountain States Tumor Institute - Meridian Recruiting
Meridian, Idaho, United States, 83642
Contact: Benjamin B. Bridges    800-845-4624      
Principal Investigator: Benjamin B. Bridges         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Abby B. Siegel    212-305-8615      
Principal Investigator: Abby B. Siegel         
United States, South Carolina
Cancer Centers of the Carolinas - Faris Recruiting
Greenville, South Carolina, United States, 29605
Contact: Mark A. O'Rourke    864-241-6251      
Principal Investigator: Mark A. O'Rourke         
Cancer Centers of the Carolinas - Grove Commons Recruiting
Greenville, South Carolina, United States, 29605
Contact: Mark A. O'Rourke    864-241-6251      
Principal Investigator: Mark A. O'Rourke         
Cancer Centers of The Carolinas Recruiting
Greenville, South Carolina, United States, 29605
Contact: Mark A. O'Rourke    864-241-6251      
Principal Investigator: Mark A. O'Rourke         
Greenville CCOP Recruiting
Greenville, South Carolina, United States, 29615
Contact: Mark A. O'Rourke    864-241-6251      
Principal Investigator: Mark A. O'Rourke         
Greenville Memorial Hospital Recruiting
Greenville, South Carolina, United States, 29605
Contact: Mark A. O'Rourke    864-241-6251      
Principal Investigator: Mark A. O'Rourke         
Cancer Centers of the Carolinas-Greer Medical Oncology Recruiting
Greer, South Carolina, United States, 29650
Contact: Mark A. O'Rourke    864-241-6251      
Principal Investigator: Mark A. O'Rourke         
Cancer Centers of the Carolinas - Seneca Recruiting
Seneca, South Carolina, United States, 29672
Contact: Mark A. O'Rourke    864-241-6251      
Principal Investigator: Mark A. O'Rourke         
Cancer Centers of the Carolinas - Spartanburg Recruiting
Spartanburg, South Carolina, United States, 29307
Contact: Mark A. O'Rourke    864-241-6251      
Principal Investigator: Mark A. O'Rourke         
United States, Texas
Southwest Oncology Group Recruiting
San Antonio, Texas, United States, 78245
Contact: Scott D. Ramsey    206-667-7846    sramsey@fhcrc.org   
Principal Investigator: Scott D. Ramsey         
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Scott D. Ramsey, M.D. Fred Hutchinson Cancer Research Center
  More Information

No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01946516     History of Changes
Other Study ID Numbers: S1204, NCI-2013-01631, U10CA032102
Study First Received: September 16, 2013
Last Updated: August 20, 2014
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
viral screening

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 30, 2014