Clincosm LogoSign in Get a demo

S1204, Viral Screening in Newly Diagnosed Cancer Patients

Sponsor
Southwest Oncology Group (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01946516
Collaborator
National Cancer Institute (NCI) (NIH)
2,863
Enrollment
58
Locations
109.1
Anticipated Duration (Months)
49.4
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    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 :
    Aug 29, 2013
    Actual Primary Completion Date :
    Jan 1, 2018
    Anticipated Study Completion Date :
    Oct 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of viral infection [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 [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. [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. [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 [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. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Kaiser Permanente Hospital Fontana California United States 92335
    2 Kaiser Permanente - Harbor City Harbor City California United States 90710
    3 Contra Costa Regional Medical Center Martinez California United States 94553-3156
    4 East Bay Physicians Medical Group-Summit Oakland California United States 94609
    5 Kaiser Permanente-Oakland Oakland California United States 94611
    6 Desert Regional Medical Center Palm Springs California United States 92262
    7 Kaiser Permanente - Panorama City Panorama City California United States 91402
    8 Kaiser Permanente-Roseville Roseville California United States 95661
    9 Kaiser Permanente-San Francisco San Francisco California United States 94115
    10 Kaiser Permanente Medical Center-Vacaville Vacaville California United States 95688
    11 Kaiser Permanente-Lone Tree Lone Tree Colorado United States 80124
    12 University of Hawaii Cancer Center Honolulu Hawaii United States 96813
    13 Tripler Army Medical Center Honolulu Hawaii United States 96859
    14 Saint Luke's Mountain States Tumor Institute - Meridian Meridian Idaho United States 83642
    15 Mac Neal Hospital Berwyn Illinois United States 60402
    16 Weiss Memorial Hospital Chicago Illinois United States 60640
    17 Hines Veterans Administration Hospital Hines Illinois United States 60141
    18 West Suburban Medical Center River Forest Illinois United States 60305
    19 Veteran Administration Eastern Kansas Healthcare Leavenworth Kansas United States 66048
    20 Topeka VA Hospital Topeka Kansas United States 66622
    21 LSU Health Baton Rouge-North Clinic Baton Rouge Louisiana United States 70805
    22 Louisiana Hematology Oncology Associates LLC Baton Rouge Louisiana United States 70809
    23 Mary Bird Perkins Cancer Center Baton Rouge Louisiana United States 70809
    24 Medical Oncology LLC Baton Rouge Louisiana United States 70809
    25 Mary Bird Cancer Center/Saint Tammany Parish Covington Louisiana United States 70433
    26 Women's Cancer Care-Covington Covington Louisiana United States 70433
    27 Mary Bird Perkins Cancer Center/Terrebonne General Medical Center Houma Louisiana United States 70360
    28 Oncology Center of The South Incorporated Houma Louisiana United States 70360
    29 East Jefferson General Hospital Metairie Louisiana United States 70006
    30 University Health-Conway Monroe Louisiana United States 71202
    31 University Medical Center New Orleans New Orleans Louisiana United States 70112
    32 Louisiana State University Health Sciences Center Shreveport Shreveport Louisiana United States 71103
    33 North Shore Hematology Oncology Associates Inc Slidell Louisiana United States 70458
    34 Boston Medical Center Boston Massachusetts United States 02118
    35 Kansas City Veterans Affairs Medical Center Kansas City Missouri United States 64128
    36 Billings Clinic Cancer Center Billings Montana United States 59101
    37 Saint James Community Hospital and Cancer Treatment Center Butte Montana United States 59701
    38 Columbia University/Herbert Irving Cancer Center New York New York United States 10032
    39 Adena Regional Medical Center Chillicothe Ohio United States 45601
    40 Columbus Oncology and Hematology Associates Inc Columbus Ohio United States 43214
    41 Grant Medical Center Columbus Ohio United States 43215
    42 OneHealth Marion General Hospital Marion Ohio United States 43302
    43 Knox Community Hospital Mount Vernon Ohio United States 43050
    44 Licking Memorial Hospital Newark Ohio United States 43055
    45 Southern Ohio Medical Center Portsmouth Ohio United States 45662
    46 Kaiser Permanente Northwest Portland Oregon United States 97227
    47 Greenville Health System Cancer Institute-Andrews Greenville South Carolina United States 29605
    48 Greenville Health System Cancer Institute-Butternut Greenville South Carolina United States 29605
    49 Greenville Health System Cancer Institute-Faris Greenville South Carolina United States 29605
    50 Greenville Memorial Hospital Greenville South Carolina United States 29605
    51 Greenville Health System Cancer Institute-Eastside Greenville South Carolina United States 29615
    52 Greenville Health System Cancer Institute-Greer Greer South Carolina United States 29650
    53 Greenville Health System Cancer Institute-Seneca Seneca South Carolina United States 29672
    54 Greenville Health System Cancer Institute-Spartanburg Spartanburg South Carolina United States 29307
    55 The Don and Sybil Harrington Cancer Center Amarillo Texas United States 79106
    56 Lyndon Baines Johnson General Hospital Houston Texas United States 77026-1967
    57 Audie L Murphy Veterans Affairs Hospital San Antonio Texas United States 78209
    58 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229

    Sponsors and Collaborators

    • Southwest Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Scott D. Ramsey, M.D., Fred Hutchinson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT01946516
    Other Study ID Numbers:
    • S1204
    • NCI-2013-01631
    • U10CA032102
    First Posted:
    Sep 19, 2013
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Keywords provided by Southwest Oncology Group
    viral screening

    Study Results

    No Results Posted as of Aug 24, 2022