NCT01946516已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,051
- 试验地点
- 58
- 主要终点
- Number of Participants With Positive Viral Infection
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.)
结局指标
主要结局
Number of Participants With Positive Viral Infection
时间窗: Up to 21 days after registration
An estimate of the prevalence of human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection among newly diagnosed cancer participants presenting to SWOG-affiliated community and academic oncology clinics.
次要结局
- Presence of Important Risk Factors in Participants Tested for HIV(Up to 21 days after registration)
- Presence of Important Risk Factors in Participants Tested for Chronic HBV(Up to 21 days after registration)
- Cost-effectiveness of Viral Screening(3 years after registration)
- Type and Rate of Adverse Events Among Patients With Viral Infection.(5 years after registration)
- Presence of Important Risk Factors in Participants Tested for Previous HBV(Up to 21 days after registration)
- Presence of Important Risk Factors in Participants Tested for HCV(Up to 21 days after registration)
- Type of Treatment for Cancer and Virus in Participants With Positive Viral Test(60 days after registration)
研究者
研究点 (58)
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