跳至主要内容
临床试验/NCT05824442
NCT05824442招募中不适用

Evaluation of a New Multiplex Quantitative PCR Technique for the Diagnosis of Echinococcosis

Centre Hospitalier Universitaire de Besancon2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2023年10月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
43
试验地点
2
主要终点
Performance indicators of a new diagnosis technique based on multiplex quantitative PCR

研究概览

简要总结

Echinococcosis is a severe parasitosis caused by the development of the tapeworm larva Echinococcus multilocularis, responsible for alveolar echinococcosis (AE) or Echinococcus granulosus, responsible for cystic echinococcosis (CE). The treatment is based on surgery (only possible in 30 to 40% of cases) and/or on a benzimidazole antiparasitic treatment, especially albendazole. Albendazole is only parasitostatic, it slows down the development of the parasite but does not kill it. It is often prescribed for life. Monitoring the effectiveness of the treatment is therefore necessary, requiring radiological and serological monitoring once or twice a year. Being a chronic disease whose treatment is not always curative, patients quality of life is impacted, with a high level of anxiety described in some patients.

The diagnosis, evoked on radiological arguments, is then confirmed by serological techniques, whose sensitivity for EA diagnosis is good (95%) in the absence of immunosuppression (now observed in 25% of EA patients). Sensitivity is lower for CE diagnosis (70% or even less than 50% in certain clinical forms).

Quantitative real-time PCR (QPCR) techniques on blood samples are now used in many infectious pathologies to quantify the circulating DNA load, and improve diagnosis and therapeutic monitoring. The presence of circulating parasitic DNA has been reported in both types of echinococcosis.

A new Echinococcus spp.multiplex QPCR technique (QPCR-Echino) allowing the detection of DNA from E. multilocularis and different species of the E. granulosus complex of European occurrence, in different types of biological samples, has recently been developed in the French National Reference Center for Echinococcosis laboratory.

The investigators wish to evaluate QPCR-Echino for the detection of DNA in tissues, as well as in blood, for the diagnosis of Echinococcosis. This technique could improve the sensitivity of biological diagnosis, especially in immunocompromised patients, who often experience significant diagnostic delays, and could also provide information on the virulence and viability of the strains involved.

研究设计

研究类型
Interventional
分配方式
Na
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

入选标准

  • Men and women aged >18 years with a diagnosis of echinococcosis (Alveolar Echinococcosis or Cystic Echinococcosis) established according to the reference criteria
  • Signature of the informed consent form indicating that the subject has understood the purpose and the procedures required by the study and that he agrees to participate in the study and to comply with the requirements and restrictions about this study
  • Affiliation to a French social security scheme or beneficiary of such a scheme.

排除标准

  • Legal incapacity or limited legal capacity
  • Subject unlikely to cooperate in the study and/or low cooperation anticipated by the investigator
  • Subject without health insurance
  • Pregnant woman
  • Subject being in the period of exclusion from another study or provided by the "national volunteer file".

结局指标

主要结局

Performance indicators of a new diagnosis technique based on multiplex quantitative PCR

时间窗: 1 year

sensitivity of DNA detection by QPCR-Echino in tissues (operating specimens, biopsies, puncture fluids) and in blood (plasma)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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