Evaluation of a New Multiplex Quantitative PCR Technique for the Diagnosis of Echinococcosis (HIS-QPCR-ECH)

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.

Study Overview

• Status: Recruiting
• Conditions: Diagnosis; Echinococcosis
• Intervention / Treatment: Biological: Blood sample for multiplex QPCR technique

• Study Type: Interventional
• Enrollment (Estimated): 43
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laurence MILLON, PharmD, PhD; Phone Number: 0370632353; Email: lmillon@chu-besancon.fr
• Study Contact Backup: Name: Jenny KNAPP, PhD; Phone Number: 0370632106; Email: jknapp@chu-besancon.fr

Study Locations

• France
  • Besancon, France, 25000
    • Recruiting
    • MILLON
    • Contact: Florent DEMONMEROT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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".

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biological sample; Blood sample	Biological: Blood sample for multiplex QPCR technique; Blood sampling specifically for qPCR Echino at inclusion and one year after

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance indicators of a new diagnosis technique based on multiplex quantitative PCR	sensitivity of DNA detection by QPCR-Echino in tissues (operating specimens, biopsies, puncture fluids) and in blood (plasma)	1 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Delphine VERHOEVEN-WEIL, MD, CHU Besancon

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: High sensitive qPCR
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Parasitic Diseases; Helminthiasis; Cestode Infections; Disease; Echinococcosis
• Other Study ID Numbers: 2022/737

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No