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

NCT05769790 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-03-15

No results posted yet for this study

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.

Conditions

  • Cystic Echinococcosis

Interventions

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.

Sponsors & Collaborators

  • IRCCS Sacro Cuore Don Calabria di Negrar

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-21
Primary Completion
2024-03-30
Completion
2024-03-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05769790 on ClinicalTrials.gov