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

NCT ID: NCT05824442

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-24
• Study Completion Date: 2026-10-31

Brief Summary

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.

Conditions

Echinococcosis; Diagnosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Biological sample

Blood sample

Group Type: EXPERIMENTAL

Blood sample for multiplex QPCR technique

Intervention Type: BIOLOGICAL

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

Interventions

Blood sample for multiplex QPCR technique

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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".

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Delphine VERHOEVEN-WEIL, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Besançon

Locations

MILLON

Besançon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Laurence MILLON, PharmD, PhD

Role: CONTACT

lmillon@chu-besancon.fr

0370632353

Jenny KNAPP, PhD

Role: CONTACT

jknapp@chu-besancon.fr

0370632106

Facility Contacts

Florent DEMONMEROT

Role: primary

Other Identifiers

2022/737

Identifier Type: -

Identifier Source: org_study_id