Droplet-digital PCR for the Detection of Circulating Cell-free DNA in Patients With Cystic Echinococcosis: an Exploratory Study

Not Applicable

Recruiting

• Conditions: Cystic Echinococcosis

• Registration Number: NCT05769790
• Lead Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar

Brief Summary

It is an experimental study, multicentre, non-profit, whose aim is to preliminarily evaluate the sensitivity of ddPCR for the detection of cfDNA in the diagnosis of cystic echinococcosis and to generate data for its potential use also for the discrimination of the presence of infection with active/inactive cysts and the post-therapy follow-up.

Detailed Description

It is an experimental study, multicentre, non-profit, whose aim is to preliminarily evaluate the sensitivity of ddPCR for the detection of cfDNA in the diagnosis of cystic echinococcosis and to generate data for its potential also use for discrimination of the presence of infection with active/inactive cysts and follow-up aftercare, to be explored in subsequent studies. For this purpose, the plasma of adult patients with untreated hepatic cystic echinococcosis will be analysed.

The analyzes will be carried out on samples of patients who have already had a definitive diagnosis of cystic echinococcosis, and therefore the results of the study analyzes will have no influence on the diagnosis and clinical management of the patient, which, therefore, will not be informed of the result of the analyzes relating to his/her sample.

Study Timeline

• Study Start: 2022-03-21
• Status Verified: 2023-03
• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-03
• Last Update Submitted: 2023-03-03
• Study First Posted: 2023-03-15
• Last Update Posted: 2023-03-15
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. age ≥18 years;
2. definite diagnosis of hepatic cystic echinococcosis, ascertained on the basis of the presence of at least one liver cyst with pathognomonic signs on ultrasound examination or the presence of at least one liver cyst without clearly visible pathognomonic signs but presence of positive serology with at least two validated commercial tests or western blot (LDBIO Diagnostics, Lyon, France) positive for anti-Echinococcus antibodies (WHO-IWGE diagnostic criteria, Brunetti et al 2010);
3. no prior therapy for cystic echinococcosis reported;
4. willingness to participate in the study by signing the Informed Consent form.

Exclusion Criteria

1. age < 18 years;
2. unconfirmed diagnosis of cystic echinococcosis; Echino_ddPCR version 1.1 of 02/14/2022
3. presence of echinococcal cysts only in extra-hepatic localization;
4. history of treatment for cystic echinococcosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
ddPCR sensitivity	6 months	Number of subjects with E. granulosus s.l. cfDNA detected by ddPCR in plasma, in relation to the total number of subjects with certain diagnosis untreated hepatic cystic echinococcosis

Secondary Outcome Measures

Name	Time	Method
ddPCR sensitivity by cyst stage	6 months	Number of subjects with cfDNA of E. granulosus s.l. detected by ddPCR in plasma, in ratio to the total number of subjects with certain diagnosis of hepatic cystic echinococcosis not treated divided by the presence of active and inactive cysts.

Trial Locations

Locations (2)

IRCCS Sacro Cuore Don Calabria hospital; 🇮🇹 Negrar, Verona, Italy

IRCCS Fondazione Policlinico San Matteo; 🇮🇹 Pavia, PV, Italy