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

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.

Study Overview

• Status: Recruiting
• Conditions: Cystic Echinococcosis
• Intervention / Treatment: Diagnostic test: ddPCR

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elvia Malo; Phone Number: +390456014854; Email: ricerca.clinica@sacrocuore.it

Study Locations

• Italy
  • PV
    • Pavia, PV, Italy
      • Recruiting
      • Irccs Fondazione Policlinico San Matteo
      • Contact: Ambra Vola
      • Principal Investigator: Ambra Vola
      • Sub-Investigator: Enrico Brunetti
  • Verona
    • Negrar, Verona, Italy, 37024
      • Recruiting
      • IRCCS Sacro Cuore Don Calabria hospital
      • Contact: Francesca Tamarozzi; Email: francesca.tamarozzi@sacrocuore.it
      • Principal Investigator: Francesca Tamarozzi
      • Sub-Investigator: Elena Pomari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ddPCR sensitivity	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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ddPCR sensitivity by cyst stage	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.	6 months

Collaborators and Investigators

• Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Anticipated): March 30, 2024
• Study Completion (Anticipated): March 30, 2024

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Parasitic Diseases; Helminthiasis; Cestode Infections; Echinococcosis
• Other Study ID Numbers: 2022-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No