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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07715435
Acronym
Echino_home
Enrollment
120
Registered
2026-07-20
Start date
2024-08-19
Completion date
2044-08-19
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Echinococcosis

Brief summary

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.

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.

Interventions

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

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.

Sponsors

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

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Development of a homemade PCR protocol for diagnostic useThrough study completion, expected to last 20 yearsDevelopment 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

MeasureTime frameDescription
Costs associated to hospitalizationThrough study completion, expected to last 20 yearsAnalysis of the costs associated to hospitalization

Countries

Italy

Contacts

CONTACTClinical Trial Center
clinicaltrialcenter@ospedale.al.it+39 0131206893

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026