COVID-19 Infection Screening in Cancer Patients (NEOSCREENCOVID)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- To evaluate the prevalence of COVID-19
研究概览
简要总结
Since December 2019, outbreak of COVID-19 caused by a novel virus SARS-Cov-2 has spread rapidly around the world and became a pandemic issue. Cancer patients seem to be at higher risk of infection and evolution to severe forms related to immunosuppression, according to the first published data from Chinese experience. However, the role of confounding factors such as age and smoking habits cannot be independently assessed. Supplementary data from a large retrospective Italian cohort suggest that the proportion of cancer patients with severe form of COVID-19 could be lower than expected. In addition, the proportion of asymptomatic SARS-Cov-2 infected cancer patients is unknown. Based on academic and expert's recommendations, most of cancer units have already modified cancer treatment during the pandemic, in order to limit the number of outpatient visits / inpatient admissions and then reduce or avoid cross infection of COVID-19, although the negative impact on patient's outcome (cancer recurrence or mortality) has not been established. Thus, a large screening for SARS-Cov-2 infection in treated cancer patients could help to: - Define an accurate prevalence of COVID-19 immunization in this population - Aggregate data on the relationship between clinical characteristics in cancer patients and COVID-19 risk. - Provide information about asymptomatic COVID-19 cases. - Organize effectively cancer units to separate infected and non-infected patients.
The RT-PCR gold-standard test for COVID-19 on nasal and pharyngeal swabs has limitations, as the test is not universally available, turnaround times can be lengthy, and reported sensitivities vary. It does not provide information about immunization status. Serological assays may be important for understanding the epidemiology of emerging SARS-Cov-2, including the burden and role of asymptomatic infections. Thus, the development of new devices or techniques for accurate diagnosis of SARS-CoV-2 infections, of fast and safe use, that could be spread in the local hospitals and clinics, would be a major advance for identifying and treating patients. In addition, information about the immunization of fragile people, such as cancer patients, could help to plan a safe strategy for anti-cancer treatment schedule and for the end of quarantine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age ≥ 18-years old;
- •Patient treated for histologically proven cancer;
- •Patient that require at least one visit for anti-cancer treatment in a one-day outpatient care units
- •Patients that have previously been tested positive with a RT-PCR test from nasal swab that have been authorized to come to the hospital (after recovery or a 14-days quarantine period, according to local guidelines) can be included.
- •Patient willing and able to provide written informed consent/assent for the trial;
- •6. Patient affiliated with a health insurance system.
排除标准
- •Patient not able to give free consent
- •Patient not able to understand the protocol;
- •Patient not able to undergo the COVID-19 test
- •Vulnerable persons as defined by article L1121-5 - 8:
- •Pregnant women, women in labour or breast-feeding mothers, persons deprived of their freedom by judicial or administrative decision, persons hospitalized without their consent by virtue of articles L. 3212-1 and L. 3213-1 and who are not subject to the provisions of article L. 1121-8
- •Persons admitted to a social or health facility for reasons other than research
- •Adults subject to a legal protection order or unable to give their consent.
研究组 & 干预措施
Experimental arm
screening using a rapid serological test with a drop of blood from a finger prick.
干预措施: rapid serological test (Other)
结局指标
主要结局
To evaluate the prevalence of COVID-19
时间窗: Day 1
The rate of prevalence will be defined as the ratio of the number of positive patients to the number of patients tested based on the rapid serological test (presence of IgM and/or IgG).
次要结局
- To evaluate patient's and health care professional's perception about the rapid serological test.(Day 1)
- To evaluate the number of patients who will get at least one new testing after the rapid serological test has been performed.(6 months)
- To evaluate the impact of COVID-19 rapid serological test on the anti-cancer treatment schedule(6 months)
- To evaluate the concordance of COVID-19 positivity by the rapid serological test compared to a classic serological test (ELISA method) from whole blood(Day 1)
- To evaluate the proportion of the patients who will have at least one positive testing among all the methods applied.(6 months)
- To compare the clinical and biological characteristics between positive and negative tested COVID-19 patients(6 months)
- To describe the outcome of COVID-19 positive patients(6 months)
- To evaluate the concordance of COVID-19 positivity by the rapid serological test compared to the gold-standard RT-PCR on nasal swab for eligible patients(Day 1)