EchinococcosisEchino_homeNCT07715435
Collection of Biological Samples From Patients With Echinococcosis and Implementation of a Home-made PCR Method
An observational study of Echinococcosis, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Echinococcosis
- What is being tested?
- Collection of biological samples from echinococcosis patients for the development of a home-based PCR protocol for diagnostic use.
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 19 Aug 2024to 19 Aug 2044
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Suspected diagnosis of echinococcosis
- Patients requiring surgery to remove cysts
- Patients aged 6 years or over
- Signature of informed consent
Who cannot join
- Patients who are candidates for surgery for other reasons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
SC Chirurgia Toracica
Alessandria, Piemonte, Italy, 15121
SC Chirurgia Toracica, +39 0131206621, SMeda@ospedale.al.it
About this study
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
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.
- Conditions
- Echinococcosis
- Being tested
- Collection of biological samples from echinococcosis patients for the development of a home-based PCR protocol for diagnostic use.
- Medical subject headings
- Echinococcosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, expected to last 20 years
Secondary outcomes (1)
Costs associated to hospitalization
Analysis of the costs associated to hospitalization
Measured: Through study completion, expected to last 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start19 Aug 2024
- Primary completion19 Aug 2034 (estimated)
- Study completion19 Aug 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EchinococcosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715435
- Sponsor's protocol ID
- ASO.ChirTor.24.01
- Acronym
- Echino_home
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07715435
- Acronym / sponsor ID
- Echino_home / ASO.ChirTor.24.01
- Conditions
- Echinococcosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaUniversity, hospital or other
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 19 Aug 2034 (estimated)
- Study completion
- 19 Aug 2044 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Suspected diagnosis of echinococcosis
- Patients requiring surgery to remove cysts
- Patients aged 6 years or over
- Signature of informed consent
Key exclusion criteria (1 listed)
- Patients who are candidates for surgery for other reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | – |
Primary outcome
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.
1 secondary outcome
Costs associated to hospitalization
Time frame: Through study completion, expected to last 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Biliary Fistulas in Surgery of Liver Echinococcosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Echinococcosis, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Center (+39 0131206893, clinicaltrialcenter@ospedale.al.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a homemade PCR protocol for diagnostic use (time frame: Through study completion, expected to last 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.