NCT05769790

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2022-03-21
• Primary completion: 2024-03-30
• Completion: 2024-03-30
• First posted: 2023-03-15
• Last updated: 2023-03-15

Locations

2 sites across 1 country: Italy