ACTION HIV (Anal Cancer TherapIes and Outcomes iNitiative for Patients Living With and Without HIV): A Global Record of Patients With Anal Squamous Cell Carcinoma With and Without HIV Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 369
- 试验地点
- 11
- 主要终点
- Median disease-free survival
研究概览
简要总结
Due to the scarcity of data on prognostic and predictive influence on CCA, epidemiological studies evaluating these factors need to be developed in patients with CCA. Therefore, the investigators want to evaluate the profile of patients in the real world and from various parts of the world, describing prognostic factors such as CD4 dosage, time of HIV infection, evaluation of viral load, diagnosis of AIDS, geographic region of diagnosis and treatment, clinical staging, medications concomitant with QRT (risk of drug interactions), comorbidities (possible impact on dose-intensity), use of HAART, time of use of HAART, radiotherapy modality (conventional 3D vs Modulated Beam Intensity [IMRT], response to Nigro vs CTII regimens, as well as comparing clinical outcomes with patients without HIV infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients 18 years of age or older
- •Confirmed histological diagnosis of anal canal squamous cell carcinoma. Basaloid subtype is accepted
- •Have underundered serological test for HIV infection
- •Any clinical stage
排除标准
- •Lack of data on treatments and clinical outcomes
研究组 & 干预措施
Without HIV Infection
Patients with CCA without HIV infection,
With HIV Infection
Patients with CCA with HIV infection,
结局指标
主要结局
Median disease-free survival
时间窗: 3 years
Defined as time from Day 1 from initiation of treatment (or definition of exclusive supportive care) to tumor death or recurrence. Disease-free survival at 3 years after initiation of treatment: proportion of patients free of local or metastatic disease at 3 years after treatment termination according to imaging tests (chest, abdomen and pelvis scans) and clinical examination of anal inspection
Complete clinical response
时间窗: 6 months
Absence of neoplasia on magnetic resonance imaging (preferred) or computed tomography of the pelvis and on clinical examination of anal inspection 6 months after the end of QRT or RT isolated
Overall survival
时间窗: From first date of treatment to date of death from any cause, assessed up to 3 years.
Defined as the date from the D1 of treatment (or exclusive supportive care) to death from any cause; living patients at the time of the analysis will be censored.
次要结局
未报告次要终点