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NCT Number: NCT05824442

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MILLON

Besançon, 25000, France

Location status: Recruiting

Location contact

Florent DEMONMEROT

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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".

Treatment and study plan

Blood sample for multiplex QPCR technique

Biological

Blood sampling specifically for qPCR Echino at inclusion and one year after

Primary outcomes

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

    Time frame: 1 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jenny KNAPP, PhD

CONTACT

[email protected]

0370632106

Laurence MILLON, PharmD, PhD

CONTACT

[email protected]

0370632353

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: HIS-QPCR-ECH

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2023
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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