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

NCT05824442 | Recruiting

• 1 other identifier: 2022/737
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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

Keywords

High sensitive qPCR

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Biological sample

EXPERIMENTAL

Blood sample

Biological: Blood sample for multiplex QPCR technique

Interventions

Blood sample for multiplex QPCR technique BIOLOGICAL

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

Biological sample

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

MILLON

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Echinococcosis; Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Cestode Infections; Helminthiasis; Parasitic Diseases; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Delphine VERHOEVEN-WEIL, MD

  CHU Besançon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurence MILLON, PharmD, PhD

CONTACT

0370632353; lmillon@chu-besancon.fr

Jenny KNAPP, PhD

CONTACT

0370632106; jknapp@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: April 21, 2023
• Study Start: October 24, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)