Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AIDS Malignancy Consortium A Trial of the AIDS Malignancy Consortium (AMC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 460
- 试验地点
- 30
- 主要终点
- Number of cancers in people with HIV (PWH) who present for care at domestic AMC sites
研究概览
简要总结
This study is being done to understand how many people with HIV (PWH) present for cancer care across the AIDS Malignancy Consortium in the United States and if there are reasons that some PWH choose to participate, or not in cancer clinical trials. Optional quality of life surveys will be used to learn more about how HIV and cancer and HIV and cancer treatment affect people.
详细描述
Primary Objective: To estimate the number of cancers in people with HIV (PWH) who present for care at domestic AMC sites
Secondary Objectives: To characterize participants that are eligible but not enrolled onto AMC clinical trials to understand site-specific and trial-specific accrual barriers
Exploratory Objectives: 1. To standardize and expand the quantity and quality of sociodemographic and cancer diagnostic and treatment characteristics collected for PWH receiving care at domestic AMC sites. 2. To describe cancer patient health-related QOL for PWH at domestic AMC sites using validated tools: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30] and Supportive Care Needs Survey Short Form 34 [SCNS-SF34]
Outline: Participants identified via screening of electronic medical records or institutional databases. All eligible participants attend one visit for the collection of broad demographic and clinical data. Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit. Data collection at study visits will occur via survey procedures and/or medical record review.
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
- •Participant can understand and is willing to sign a written informed consent document.
- •HIV positive. Documentation of HIV-1 infection by means of any one of the following:
- •Documentation of an HIV diagnosis in the medical record by a licensed health care provider;
- •Documentation of receipt of antiretroviral therapy (ART) (i.e., at least two different medications that do not constitute a prescription for pre-exposure prophylaxis [PrEP]) by a licensed health care provider. Documentation may be a record of an ART prescription in the medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name;
- •HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating >1000 RNA copies/mL;
- •Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay.
- •Note: The term "licensed" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally (e.g., U.S. FDA).
- •WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay, or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), a Western blot, or a plasma HIV-1 RNA viral load.
- •Patient was diagnosed with or treated for cancer within the last 5 years. Participants will qualify under one of three categories:
- •New, primary or recurrent diagnosis -Considering or currently receiving cancer treatment
- •Metastatic or locally advanced cancer - This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
- •Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
- •Age ≥ 18 years.
- •Participant presents to an AMC domestic clinical trial site for either clinical care or research.
排除标准
- •Participants who do not fulfill the criteria as listed above are ineligible.
研究组 & 干预措施
New, primary or recurrent disease
Considering or currently receiving cancer treatment
干预措施: Non-Interventional (Other)
New, primary or recurrent disease
Considering or currently receiving cancer treatment
干预措施: Non-Interventional Follow-up (Other)
Metastic or locally advanced cancer
This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
干预措施: Non-Interventional (Other)
Metastic or locally advanced cancer
This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
干预措施: Non-Interventional Follow-up (Other)
Prior cancer
Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
干预措施: Non-Interventional (Other)
结局指标
主要结局
Number of cancers in people with HIV (PWH) who present for care at domestic AMC sites
时间窗: Enrollment
For each cancer group listed below, the number of new and existing cases per month will be estimated. The distribution of cancer types will be computed as percentages and compared to the cancer type distribution in the HIV/AIDS Cancer Match (HACM) Study: 1. Solid organ tumors associated with human papillomavirus (HPV) infection 2. Solid organ tumors unrelated to HPV 3. Kaposi sarcoma 4. Hematologic malignancies
Number of Cancers in People With HIV (PWH) Who Present for Care at Domestic AMC Sites
时间窗: Enrollment
For each cancer group listed below, the number of new and existing cases per month will be estimated. The distribution of cancer types will be computed as percentages and compared to the cancer type distribution in the HIV/AIDS Cancer Match (HACM) Study: 1. Solid organ tumors associated with human papillomavirus (HPV) infection 2. Solid organ tumors unrelated to HPV 3. Kaposi sarcoma 4. Hematologic malignancies
次要结局
- Proportion of participants eligible for AMC trials who are successfully enrolled(Baseline and 12 weeks)
- Proportion of Participants Eligible for AMC Trials Who Are Successfully Enrolled(Baseline)