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

Italy20 participantsStarted 2022-03-21

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

ddPCR sensitivity

Timeframe: 6 months

Trial details

NCT IDNCT05769790

SponsorIRCCS Sacro Cuore Don Calabria di Negrar

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-30

Contact for this trial

Elvia Malo

+390456014854 ricerca.clinica@sacrocuore.it

View on ClinicalTrials.gov More Cystic Echinococcosis trials