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

NCT ID: NCT05769790

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-21
• Study Completion Date: 2024-03-30

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.

Conditions

Cystic Echinococcosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

ddPCR

The search for cfDNA will be performed using assays available in the literature for the search for E. granulosus cfDNA developed for PCR analysis in biological samples, targeting EgG1 Hae III repeat region, cox1 and nad1 (Zhao et al 2021). Appropriate controls (synthetic sequences and Parasitic reference DNA, provided by the Echinococcosis Reference Center of the Istituto Superiore di Sanità, Rome) will be included in each experiment.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Sacro Cuore Don Calabria di Negrar

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Fondazione Policlinico San Matteo

Pavia, PV, Italy

Site Status: RECRUITING

IRCCS Sacro Cuore Don Calabria hospital

Negrar, Verona, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Elvia Malo

Role: CONTACT

ricerca.clinica@sacrocuore.it

+390456014854

Facility Contacts

Ambra Vola

Role: primary

Francesca Tamarozzi

Role: primary

francesca.tamarozzi@sacrocuore.it

Other Identifiers

2022-02

Identifier Type: -

Identifier Source: org_study_id