Collection of Biological Samples From Patients With Echinococcosis and Implementation of a Home-made PCR Method
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Collection of biological samples from echinococcosis patients for the development of a home-based PCR protocol for diagnostic use..
- Who it may be relevant to
- Registry conditions: Echinococcosis. Basic parameters: from 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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
- Other Collection 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.
Primary outcome measures
- Development of a homemade PCR protocol for diagnostic use [Time frame: Through study completion, expected to last 20 years]
Secondary outcome measures (1)
- Costs associated to hospitalization [Time frame: Through study completion, expected to last 20 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Italy · 1 center
- SC Chirurgia Toracica — Alessandria
Identifiers
NCT: NCT07715435 · ASO.ChirTor.24.01