ClinicalTrials.gg
RecruitingNCT07715435Echino_homeUpdated Jul 20, 2026

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

An observational study in Echinococcosis, sponsored by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria. Recruiting at 1 site in Italy. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.

Sponsored by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria · Observational

From the registry’s dates

  • Started Aug 2024; still recruiting 2 years 2 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
120
Ages
6 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Echinococcosis

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03

In context

Echinococcosis

25 studies on the registry are indexed under Echinococcosis; 4 are open to participants now.

This study's planned enrollment of 120 is above the median of 45 across 18 observational studies indexed under Echinococcosis.

Browse Echinococcosis studies →

Lead sponsor

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria is the lead sponsor of 37 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients who are candidates for surgery for other reasons
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

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.

06

What researchers measure

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. Costs associated to hospitalization

    Analysis of the costs associated to hospitalization

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

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Study locations

1 of 1 sites recruiting
  • SC Chirurgia Toracica
    Alessandria, Piemonte, Italy 15121, Italy
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2024 (actual). Primary completion is estimated for Aug 2034, 120 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 15, 2026
First posted
Jul 20, 2026
StartActual
Aug 19, 2024
Primary completionEst.
Aug 19, 2034
CompletionEst.
Aug 19, 2044
Last update
Jul 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07715435
Lead sponsor
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Responsible party
Sponsor
First posted
Jul 20, 2026
Start date
Aug 19, 2024
Primary completion
Aug 19, 2034 (estimated)
Completion
Aug 19, 2044 (estimated)
Last update
Jul 20, 2026

Study contacts

Clinical Trial Center
Contact
clinicaltrialcenter@ospedale.al.it
+39 0131206893

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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