Collection of Biological Samples From Patients With Echinococcosis and Implementation of a Home-made PCR Method (Echino_home)

Pilot Observational Study Involving the Collection of Biological Samples and Clinical Data From Patients With Echinococcosis: Implementation and Evaluation of a Home-made PCR Method

Echinococcosis is a zoonotic disease caused by Echinococcus species. Diagnosis currently relies on imaging, serology and microscopy, but microscopy is time-consuming, has limited sensitivity and cannot distinguish between Echinococcus species. Molecular methods such as PCR may therefore provide a faster, more sensitive and species-specific diagnostic approach, with both clinical and epidemiological value. This study aims to improve molecular diagnosis and knowledge of pulmonary echinococcosis.

Study Overview

• Status: Recruiting
• Conditions: Echinococcosis
• Intervention / Treatment: Other: Collection of biological samples from echinococcosis patients for the development of a home-based PCR protocol for diagnostic use.

Detailed Description

Echinococcosis is a parasitic zoonotic disease caused by Echinococcus species. Current diagnosis mainly relies on imaging, serology and microscopy. However, microscopy may have limited sensitivity and cannot reliably distinguish between species.

The primary aim of this study is to collect biological samples and develop an in-house PCR diagnostic protocol.

The PCR will detect parasitic genetic material and differentiate among four Echinococcus species, and the molecular results will be compared with conventional serology and microscopy. Whole-genome sequencing will also be used for species characterisation.

In synthesis, the study aims to improve molecular diagnosis and knowledge of pulmonary echinococcosis.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Clinical Trial Center; Phone Number: +39 0131206893; Email: clinicaltrialcenter@ospedale.al.it

Study Locations

• Italy
  • Piemonte, Italy
    • Alessandria, Piemonte, Italy, Italy, 15121
      • Recruiting
      • SC Chirurgia Toracica
      • Contact: SC Chirurgia Toracica; Phone Number: +39 0131206621; Email: SMeda@ospedale.al.it

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Participants with suspected pulmonary echinococcosis who require surgery at the Thoracic Surgery Department of the SS Antonio e Biagio e C. Arrigo University Hospital in Alessandria will be enrolled in the study

Description

Inclusion Criteria:

• Suspected diagnosis of echinococcosis
• Patients requiring surgery to remove cysts
• Patients aged 6 years or over
• Signature of informed consent

Exclusion Criteria:

• Patients who are candidates for surgery for other reasons

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of a homemade PCR protocol for diagnostic use	Development of a homemade PCR protocol for diagnostic use, aimed at detecting genetic material of parasitic origin in lesions or biopsy specimens caused by Echinococcus spp.	Through study completion, expected to last 20 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Costs associated to hospitalization	Analysis of the costs associated to hospitalization	Through study completion, expected to last 20 years

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2024
• Primary Completion (Estimated): August 19, 2034
• Study Completion (Estimated): August 19, 2044

Study Registration Dates

• First Submitted: July 15, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Parasitic Diseases; Cestode Infections; Helminthiasis; Echinococcosis
• Other Study ID Numbers: ASO.ChirTor.24.01

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