Droplet-digital PCR for the Detection of Circulating Cell-free DNA in Patients With Cystic Echinococcosis: an Exploratory Study
Echino_ddPCR
1 other identifier
interventional
20
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2022
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 21, 2022
CompletedFirst Submitted
Initial submission to the registry
March 3, 2023
CompletedFirst Posted
Study publicly available on registry
March 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2024
CompletedMarch 15, 2023
March 1, 2023
2 years
March 3, 2023
March 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
ddPCR sensitivity
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
6 months
Secondary Outcomes (1)
ddPCR sensitivity by cyst stage
6 months
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
IRCCS Fondazione Policlinico San Matteo
Pavia, PV, Italy
IRCCS Sacro Cuore Don Calabria hospital
Negrar, Verona, 37024, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2023
First Posted
March 15, 2023
Study Start
March 21, 2022
Primary Completion
March 30, 2024
Study Completion
March 30, 2024
Last Updated
March 15, 2023
Record last verified: 2023-03