Hospital General Universitario de Elche and Universidad Miguel Hernández de Elche, Elche, Spain.
Hospital General Universitario de Elche, Elche, Spain.
Trials. 2021 Nov 27;22(1):851. doi: 10.1186/s13063-021-05777-6.
The incidence of non-AIDS defining cancer (NADC) is higher in people living with HIV (PLWH) than in the general population, and it is already one of the leading causes of death in the HIV-infected population. It is estimated that the situation will be aggravated by the progressive aging of PLWH. Early diagnosis through intensive cancer screening may improve the ability for therapeutic interventions and could be critical in reducing mortality, but it might also increase expenditure and harms associated with adverse events. The aim of this study is to evaluate an enhanced screening program for early diagnosis of cancer in PLWH compared to standard practice. The specific objectives are (1) to compare the frequency of cancer diagnosed at an early stage, (2) to analyze safety of the enhanced program: adverse events and unnecessary interventions, (3) to analyze the cost-utility of the program, and (4) to estimate the overall and site-specific incidence of NADC in PLWH.
We will conduct a multicenter, non-blinded, randomized, controlled trial, comparing two parallel arms: conventional vs enhanced screening. Data will be recorded in an electronic data collection notebook. Conventional intervention group will follow the standard of care screening in the participating centers, according to the European AIDS Clinical Society recommendations, and the enhanced intervention group will follow an expanded screening aimed to early detection of lung, liver, anal, cervical, breast, prostate, colorectal, and skin cancer. The trial will be conducted within the framework of the Spanish AIDS Research Network Cohort (CoRIS).
The trial will evaluate the efficacy, safety, and efficiency of an enhanced screening program for the early diagnosis of cancer in HIV patients compared to standard of care practice. The information provided will be relevant since there are currently no studies on expanded cancer screening strategies in patients with HIV, and available data estimating cost effectiveness or cost-utility of such as programs are scarce. An enhanced program for NADC screening in patients with HIV could lead to early diagnosis and improve the prognosis of these patients, with an acceptable rate of unnecessary interventions, but it is critical to demonstrate that the benefits clearly outweigh the harms, before the strategy could be implemented.
ClinicalTrials.gov NCT04735445. Registered on 25 June 2019.
与一般人群相比，HIV 感染者（PLWH）中非艾滋病定义性癌症（NADC）的发病率更高，且已成为 HIV 感染者死亡的主要原因之一。预计随着 PLWH 的逐渐老龄化，这种情况将会加剧。通过强化癌症筛查进行早期诊断，可以提高治疗干预的能力，并可能对降低死亡率至关重要，但也可能会增加与不良事件相关的支出和危害。本研究旨在评估与标准实践相比，PLWH 中用于早期诊断癌症的强化筛查方案。具体目标是：（1）比较早期诊断出的癌症的频率；（2）分析强化方案的安全性：不良事件和不必要的干预；（3）分析方案的成本效益；（4）估计 PLWH 中非艾滋病定义性癌症的总体和特定部位的发病率。
我们将开展一项多中心、非盲、随机、对照试验，比较两个平行组：常规组与强化组。数据将记录在电子数据采集笔记本中。常规干预组将根据参与中心的标准护理筛查，遵循欧洲艾滋病临床学会的建议，强化干预组将遵循旨在早期发现肺癌、肝癌、肛门癌、宫颈癌、乳腺癌、前列腺癌、结直肠癌和皮肤癌的扩展筛查。该试验将在西班牙艾滋病研究网络队列（CoRIS）的框架内进行。
该试验将评估与标准护理实践相比，针对 HIV 患者早期诊断癌症的强化筛查方案的疗效、安全性和效率。鉴于目前尚无关于 HIV 患者扩展癌症筛查策略的研究，且关于此类方案的成本效益或成本效用的现有数据也很匮乏，因此该研究提供的信息具有重要意义。在 HIV 患者中开展 NADC 筛查的强化方案，可能会实现早期诊断并改善这些患者的预后，同时不必要干预的发生率也可接受，但在实施该策略之前，必须证明其获益明显超过危害。
ClinicalTrials.gov NCT04735445。注册于 2019 年 6 月 25 日。
