Droplet-digital PCR for the Detection of Circulating Cell-free DNA in Patients With Cystic Echinococcosis: an Exploratory Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 20
- Locations
- 3
- Primary Endpoint
- ddPCR sensitivity
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age ≥18 years;
- •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);
- •no prior therapy for cystic echinococcosis reported;
- •willingness to participate in the study by signing the Informed Consent form.
Exclusion Criteria
- •age < 18 years;
- •unconfirmed diagnosis of cystic echinococcosis; Echino_ddPCR version 1.1 of 02/14/2022
- •presence of echinococcal cysts only in extra-hepatic localization;
- •history of treatment for cystic echinococcosis.
Outcomes
Primary Outcomes
ddPCR sensitivity
Time Frame: 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 Outcomes
- ddPCR sensitivity by cyst stage(6 months)