Human Leishmaniasis: Antigen Recognition Pattern and Study of New Potential Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Biomarkers from Leishmania spp
研究概览
简要总结
This is an exploratory experimental multicentre study on archived serum samples and on prospectively collected serum samples and blood samples.
General objectives of the study are: to identify specific biomarkers in order to develop more accurate serological tests for the screening of Leishmania infections that does not present cross-reaction with other infectious diseases; to unveil the Antigen Recognition Patterns (ARPs) of Leishmania infection in humans; to verify whether the ARPs and the new biomarkers are common to different Leishmania infantum strains isolated in Italy as well as in other part of the World and to different strains of L. donovani isolated in Sudan as well as in other part of the World and discard any possible cross reaction with other infectious diseases such as Chagas, TB, leprosy or malaria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Inclusion criteria:
- •Leishmania positive patient from Italy (n=30) and from Sudan (n=30);
- •patient with a clinically or laboratory confirmed diagnosis of leishmaniasis;
- •signed informed consent (criteria not applied in case of samples stored at the Tropica Biobank at the DITM)
- •being clinically classified as leishmaniasis patient by an experienced clinician or being laboratory confirmed as leishmaniasis patients, giving positive to at least two different serological tests or to a molecular test for Leishmania sp.
- •adult subjects (equal or older than 18 years)
排除标准
- •lack of the necessary data and/or of biological samples
- •subjects younger than 18 years
- •COMMUNITY CONTROLS:
- •Inclusion criteria:
- •Cryo-preserved serum samples stored at the Tropica Biobank at the DITM , IRCCS Sacro Cuore Don Calabria Hospital, Negrar (Vr), from subject from Italy (n=30) and from Africa (n=30) with no infection due by Leishmania spp.
- •signed informed consent to Tropica Biobank
- •adult subjects (equal or older than 18 years)
- •being negative to two different serological tests for leishmaniasis
- •Exclusion criteria:
- •subjects younger than 18 years
- •being positive to one serological tests for leishmaniasis.
- •VALIDATION CONTROLS (VC):
- •Inclusion criteria:
- •serum samples stored in Tropica Biobank at the DITM from subjects that have been clinically diagnosed with Chagas's disease, or TB, or malaria or leprosy.
- •informed consent signed to Tropical Biobank
- •adult subjects (equal or older than 18 years)
- •being negative to two different serological tests for leishmaniasis.
- •being clinically diagnosed with Chagas disease or TB, or malaria or leprosy
- •Exclusion criteria:
- •younger than 18 years
- •positive result to one serological test for leishmaniasis.
结局指标
主要结局
Biomarkers from Leishmania spp
时间窗: Baseline
Presence/Absence of a reactive immunogenic band or a pattern of reactive immunogenic bands in an in-house Western blot, specific for Leishmania cases respect to negative controls.
次要结局
- Cross reaction(Baseline)
- ARPs in different Leishmania infantum and L. donovani strains(Baseline)