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NCT Number: NCT07715435

Collection of Biological Samples From Patients With Echinococcosis and Implementation 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.

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Key information

Conditions

Echinococcosis Cestode Infections Helminthiasis Infections Parasitic Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SC Chirurgia Toracica

Alessandria, Piemonte, Italy, 15121, Italy

Location status: Recruiting

Location contact

SC Chirurgia Toracica

CONTACT

[email protected]

+39 0131206621

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Collection of biological samples from echinococcosis patients for the development of a home-based PCR protocol for diagnostic use.

Other

Collection of series of biological samples from patients with echinococcosis for the development and optimisation of a home-made PCR protocol for diagnostic use; this will serve as a resource for research, becoming an important tool for the study of this zoonosis in conjunction with the clinical, microbiological and family history data of the affected individual.

Primary outcomes

  1. Development of a homemade PCR protocol for diagnostic use

    Time frame: Through study completion, expected to last 20 years

    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.

Secondary outcomes

  1. Costs associated to hospitalization

    Time frame: Through study completion, expected to last 20 years

    Analysis of the costs associated to hospitalization

Study contacts

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

Clinical Trial Center

CONTACT

[email protected]

+39 0131206893

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Other

Registry information

Official study title

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

Acronym: Echino_home

Important dates

Study start
2024
Primary completion
2034
Study completion
2044
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

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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