Clinical trial NCT05769790: Droplet-digital PCR for the Detection of Circulating Cell-free DNA in Patients With Cystic Echinococcosis: an Exploratory Study
Official title: Droplet-digital PCR for the Detection of Circulating Cell-free DNA in Patients With Cystic Echinococcosis: an Exploratory Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cystic Echinococcosis
Lead sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: ddPCR sensitivity
timeFrame: 6 months
Secondary outcomes:
measure: ddPCR sensitivity by cyst stage
timeFrame: 6 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS Fondazione Policlinico San Matteo
state: PV
city: Negrar
country: Italy
facility: IRCCS Sacro Cuore Don Calabria hospital
state: Verona
Study officials:
References: