跳至主要内容
临床试验/NCT04735445
NCT04735445Unknown不适用

IMPACt of an Enhanced Screening Program on the Detection of Non-AIDS NEOplasms in Patients With Human Immunodeficiency Virus (HIV) Infection

Felix Gutierrez1 个研究点 分布在 1 个国家目标入组 4,638 人开始时间: 2019年11月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
4,638
试验地点
1
主要终点
Non-AIDS defining cancers incidence

研究概览

简要总结

Introduction: The incidence of malignancies is higher in the HIV-infected population than in the general population, and it is already one of the leading causes of death in people living with the virus. It is estimated that the situation will be aggravated by the progressive aging of the HIV-infected population. Early diagnosis through enhanced cancer screening can be critical in reducing mortality, but may increase expenditure and harms associated with adverse events. This strategy should then be considered only when the benefits clearly outweigh the harms. There are currently no studies on expanded cancer screening in patients with HIV, and available information from the point of view of costeffectiveness or cost-utility is scarce.

Hypothesis: An enhanced program for non-aids cancer screening in patients with HIV can lead to early diagnosis and improve the prognosis of these patients, with an acceptable rate of unnecessary interventions and being cost-effective.

Objectives: To evaluate the efficacy, safety and efficiency of an enhanced screening program for the early diagnosis of cancer in HIV patients compared to standard practice within the cohort of the National AIDS Research Network (CoRIS).

Specific objectives: 1) To compare the incidence of early diagnosed cancer with enhanced screening versus conventional screening; 2) To assess the incidence of early diagnosed cancer and its overall incidence in the CoRIS cohort; 3) To analyze safety of the program: adverse events and unnecessary interventions; 4) To compare the obtained data stratifying by gender and 5) To analyze the cost-utility of the program.

Expected results: 1) To generate scientific evidence to inform decision makers on the advisability of implementing an enhanced screening program of cancer in HIV-infected patients; 2) To broaden knowledge about the programs of early detection of cancer in vulnerable populations and their economic evaluation from the perspective of the National Health Service.

详细描述

Non-AIDS-Defining Cancers (NADCs) are an important cause of morbidity and mortality in the population living with the human immunodeficiency virus (PLHIV), being currently one of the most frequent causes of death. Due to several reasons, the incidence of this type of tumors in PLHIV has increased 2-3 times with respect to the general population (GP). In a recent systematic review, with more than 600,000 PLHIV and 10,891 new cases of cancer, it is demonstrated how the incidence of NADCs has progressively increased since the introduction of combined antiretroviral therapy (ART), probably reflecting better viral-immune control and aging associated with the increase in overall survival of patients living with the virus. The most frequent cancers are lung cancer, hepatocellular carcinoma, anal carcinoma and cervical carcinoma, although some studies have suggested that there could also be a higher incidence and / or severity of other malignant tumors, such as breast cancer, prostate, colorectal or skin, including melanomas. In the era of ART, lung cancer has become the most frequent and deadliest cause of non-AIDS-associated cancer in PLHIV, and greater lethality has been documented in PLHIV than in GP.

The causes of this increased incidence of NADCs are not well known and there are several factors that could influence, including the oncogenic effects of the virus, immunosuppression, chronic inflammation and immune activation, ART exposure, higher rates of coinfection with other oncogenic viruses and traditional cancer risk factors such as smoking. It is estimated that at least 1 in 3 PLHIV will die due to malignant neoplasms in the coming years. There is currently no consensus on the best screening strategies in this population, strategies that seem increasingly necessary considering the progressive aging of the infected population and the increase in the incidence of these neoplasms.

In some of the clinical practice guidelines in PLHIV, such as the Spanish Gesida or other European ones, the screening strategies for neoplasms recommended in GP have been incorporated, in which they have shown benefit in terms of mortality or greater probabilities of therapeutic success. However, these benefits have not been confirmed in PLHIV, in which this type of strategy could be insufficient.

Moreover, there are currently no established recommendations for GP screening on two of the main neoplasms of PLHIV, such as lung and anal. For this reason, it is necessary to generate scientific evidence that determines which is the most convenient strategy to reduce the morbidity and mortality associated with NADCs in PLHIV. Then, the evaluation of an enhanced program of screening by conducting a clinical trial, in which patients are randomized to one of the two strategies (enhanced screening versus standard of care practice), is the ideal design to generate scientific evidence. This knowledge could be useful to determine if the benefits of the enhanced screening outweighs the harms and if it is cost-effective for the National Health Service.

Objectives:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

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

  • •Male ≥40 years or woman ≥18 years
  • •Informed Consent signed

排除标准

  • •Active AIDS defining disease
  • •Antecedent of cancer
  • •Terminal disease
  • •Pregnancy or breastfeeding
  • •Patient rejection

研究组 & 干预措施

Conventional screening

Active Comparator

Standard screening in the participating centers, adjusted to the recommendations of the European AIDS Society (EACS).

干预措施: Semestral appointment for liver ultrasound (Diagnostic Test)

Conventional screening

Active Comparator

Standard screening in the participating centers, adjusted to the recommendations of the European AIDS Society (EACS).

干预措施: Digital rectal exam and / or anal cytology (day 1 and after 36 months) (Diagnostic Test)

Conventional screening

Active Comparator

Standard screening in the participating centers, adjusted to the recommendations of the European AIDS Society (EACS).

干预措施: Cervical cytology and cervical sample for HPV detection (day 1 and after 36 months) (Diagnostic Test)

Conventional screening

Active Comparator

Standard screening in the participating centers, adjusted to the recommendations of the European AIDS Society (EACS).

干预措施: Appointment for mammography (day 1 and after 36 months) (Diagnostic Test)

Conventional screening

Active Comparator

Standard screening in the participating centers, adjusted to the recommendations of the European AIDS Society (EACS).

干预措施: Fecal occult blood test (day 1 and after 36 months) (Diagnostic Test)

Conventional screening

Active Comparator

Standard screening in the participating centers, adjusted to the recommendations of the European AIDS Society (EACS).

干预措施: Digital rectal exam and PSA determination (day 1 and after 36 months) (Diagnostic Test)

Enhanced screening

Experimental

Expanded screening for early detection of lung, liver, anal, cervical, breast, prostate, colorectal and skin cancer.

干预措施: Semestral digital rectal exam and / or anal cytology if abnormal → ANOSCOPY with biopsy (Diagnostic Test)

Enhanced screening

Experimental

Expanded screening for early detection of lung, liver, anal, cervical, breast, prostate, colorectal and skin cancer.

干预措施: Semestral cervical cytology and cervical sample for HPV detection (Diagnostic Test)

Enhanced screening

Experimental

Expanded screening for early detection of lung, liver, anal, cervical, breast, prostate, colorectal and skin cancer.

干预措施: Annual appointment for mammography (Diagnostic Test)

Enhanced screening

Experimental

Expanded screening for early detection of lung, liver, anal, cervical, breast, prostate, colorectal and skin cancer.

干预措施: Semestral appointment for liver ultrasound (Diagnostic Test)

Enhanced screening

Experimental

Expanded screening for early detection of lung, liver, anal, cervical, breast, prostate, colorectal and skin cancer.

干预措施: Semestral blood collection for alpha-fetoprotein and others hepatic biomarkers determination (Diagnostic Test)

Enhanced screening

Experimental

Expanded screening for early detection of lung, liver, anal, cervical, breast, prostate, colorectal and skin cancer.

干预措施: Annual fecal occult blood test (Diagnostic Test)

Enhanced screening

Experimental

Expanded screening for early detection of lung, liver, anal, cervical, breast, prostate, colorectal and skin cancer.

干预措施: Annual digital rectal exam and PSA determination (Diagnostic Test)

Enhanced screening

Experimental

Expanded screening for early detection of lung, liver, anal, cervical, breast, prostate, colorectal and skin cancer.

干预措施: Annual appointment for low dose computed tomography for lung screening (Diagnostic Test)

Enhanced screening

Experimental

Expanded screening for early detection of lung, liver, anal, cervical, breast, prostate, colorectal and skin cancer.

干预措施: Annual general inspection for skin lesions suggestive of malignancy (Diagnostic Test)

结局指标

主要结局

Non-AIDS defining cancers incidence

时间窗: through study completion, an average of 1 year

The incidence of different neoplasms not considered as AIDS defining cancers compared between two arms

Survival rate

时间窗: through study completion, an average of 1 year

Comparison in survival terms between conventional and enhanced screening arms

次要结局

  • Safety of the screening: adverse events(through study completion, an average of 1 year)
  • Cost-efectiveness(through study completion, an average of 1 year)

研究者

发起方
Felix Gutierrez
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Felix Gutierrez

Principal Investigator

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

研究点 (1)

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