Clinical trial NCT01946516: S1204, Viral Screening in Newly Diagnosed Cancer Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: viral screening
Lead sponsor: SWOG Cancer Research Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-09-19
Enrollment: 3051
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community and academic oncology clinics

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.

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 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.)

Primary outcomes:
measure: Number of Participants With Positive Viral Infection
timeFrame: Up to 21 days after registration
Secondary outcomes:
measure: Presence of Important Risk Factors in Participants Tested for Previous HBV
timeFrame: Up to 21 days after registration
measure: Presence of Important Risk Factors in Participants Tested for Chronic HBV
timeFrame: Up to 21 days after registration
measure: Presence of Important Risk Factors in Participants Tested for HCV
timeFrame: Up to 21 days after registration
measure: Presence of Important Risk Factors in Participants Tested for HIV
timeFrame: Up to 21 days after registration
measure: Type of Treatment for Cancer and Virus in Participants With Positive Viral Test
timeFrame: 60 days after registration
measure: Type and Rate of Adverse Events Among Patients With Viral Infection.
timeFrame: 5 years after registration
measure: Cost-effectiveness of Viral Screening
timeFrame: 3 years after registration
Other outcomes:
Locations:
city: Fontana
country: United States
facility: Kaiser Permanente Hospital
state: California
city: Harbor City
country: United States
facility: Kaiser Permanente - Harbor City
state: California
city: Martinez
country: United States
facility: Contra Costa Regional Medical Center
state: California
city: Oakland
country: United States
facility: East Bay Physicians Medical Group-Summit
state: California
city: Oakland
country: United States
facility: Kaiser Permanente-Oakland
state: California
city: Palm Springs
country: United States
facility: Desert Regional Medical Center
state: California
city: Panorama City
country: United States
facility: Kaiser Permanente - Panorama City
state: California
city: Roseville
country: United States
facility: Kaiser Permanente-Roseville
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente-San Francisco
state: California
city: Vacaville
country: United States
facility: Kaiser Permanente Medical Center-Vacaville
state: California
city: Lone Tree
country: United States
facility: Kaiser Permanente-Lone Tree
state: Colorado
city: Honolulu
country: United States
facility: University of Hawaii Cancer Center
state: Hawaii
city: Honolulu
country: United States
facility: Tripler Army Medical Center
state: Hawaii
city: Meridian
country: United States
facility: Saint Luke's Mountain States Tumor Institute - Meridian
state: Idaho
city: Berwyn
country: United States
facility: Mac Neal Hospital
state: Illinois
city: Chicago
country: United States
facility: Weiss Memorial Hospital
state: Illinois
city: Hines
country: United States
facility: Hines Veterans Administration Hospital
state: Illinois
city: River Forest
country: United States
facility: West Suburban Medical Center
state: Illinois
city: Leavenworth
country: United States
facility: Veteran Administration Eastern Kansas Healthcare
state: Kansas
city: Topeka
country: United States
facility: Topeka VA Hospital
state: Kansas
city: Baton Rouge
country: United States
facility: LSU Health Baton Rouge-North Clinic
state: Louisiana
city: Baton Rouge
country: United States
facility: Louisiana Hematology Oncology Associates LLC
state: Louisiana
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center
state: Louisiana
city: Baton Rouge
country: United States
facility: Medical Oncology LLC
state: Louisiana
city: Covington
country: United States
facility: Mary Bird Cancer Center/Saint Tammany Parish
state: Louisiana
city: Covington
country: United States
facility: Women's Cancer Care-Covington
state: Louisiana
city: Houma
country: United States
facility: Mary Bird Perkins Cancer Center/Terrebonne General Medical Center
state: Louisiana
city: Houma
country: United States
facility: Oncology Center of The South Incorporated
state: Louisiana
city: Metairie
country: United States
facility: East Jefferson General Hospital
state: Louisiana
city: Monroe
country: United States
facility: University Health-Conway
state: Louisiana
city: New Orleans
country: United States
facility: University Medical Center New Orleans
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center Shreveport
state: Louisiana
city: Slidell
country: United States
facility: North Shore Hematology Oncology Associates Inc
state: Louisiana
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Kansas City
country: United States
facility: Kansas City Veterans Affairs Medical Center
state: Missouri
city: Billings
country: United States
facility: Billings Clinic Cancer Center
state: Montana
city: Butte
country: United States
facility: Saint James Community Hospital and Cancer Treatment Center
state: Montana
city: New York
country: United States
facility: Columbia University/Herbert Irving Cancer Center
state: New York
city: Chillicothe
country: United States
facility: Adena Regional Medical Center
state: Ohio
city: Columbus
country: United States
facility: Columbus Oncology and Hematology Associates Inc
state: Ohio
city: Columbus
country: United States
facility: Grant Medical Center
state: Ohio
city: Marion
country: United States
facility: OneHealth Marion General Hospital
state: Ohio
city: Mount Vernon
country: United States
facility: Knox Community Hospital
state: Ohio
city: Newark
country: United States
facility: Licking Memorial Hospital
state: Ohio
city: Portsmouth
country: United States
facility: Southern Ohio Medical Center
state: Ohio
city: Portland
country: United States
facility: Kaiser Permanente Northwest
state: Oregon
city: Greenville
country: United States
facility: Greenville Health System Cancer Institute-Andrews
state: South Carolina
city: Greenville
country: United States
facility: Greenville Health System Cancer Institute-Butternut
state: South Carolina
city: Greenville
country: United States
facility: Greenville Health System Cancer Institute-Faris
state: South Carolina
city: Greenville
country: United States
facility: Greenville Memorial Hospital
state: South Carolina
city: Greenville
country: United States
facility: Greenville Health System Cancer Institute-Eastside
state: South Carolina
city: Greer
country: United States
facility: Greenville Health System Cancer Institute-Greer
state: South Carolina
city: Seneca
country: United States
facility: Greenville Health System Cancer Institute-Seneca
state: South Carolina
city: Spartanburg
country: United States
facility: Greenville Health System Cancer Institute-Spartanburg
state: South Carolina
city: Amarillo
country: United States
facility: The Don and Sybil Harrington Cancer Center
state: Texas
city: Houston
country: United States
facility: Lyndon Baines Johnson General Hospital
state: Texas
city: San Antonio
country: United States
facility: Audie L Murphy Veterans Affairs Hospital
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Scott D. Ramsey, M.D.
role: STUDY_CHAIR
References: