Droplet-digital PCR for the Detection of Circulating Cell-free DNA in Patients With Cystic Echinococcosis: an Exploratory Study
Echino_ddPCR
Echino_ddPCR
Sponsor study identifier
interventional
20
1 country
2
Study Start
March 21, 2022
Actual (reported)Primary Completion
March 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 21, 2022
Actual (reported)March 3, 2023
Actual (reported)March 15, 2023
Actual (reported)March 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
ddPCR sensitivity by cyst stage
6 months
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
IRCCS Fondazione Policlinico San Matteo
Pavia, PV, Italy
IRCCS Sacro Cuore Don Calabria hospital
Negrar, Verona, 37024, Italy
First Submitted
March 3, 2023
First Posted
March 15, 2023
Study Start
March 21, 2022
Actual (reported)Primary Completion
March 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Fertility Preservation in Children With Solid Tumors: Detection of Residual Disease by a Sensitive Method
Contact the study team to confirm eligibility.
Study Completion
March 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 15, 2023
Record last verified: 2023-03
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Source: ClinicalTrials.gov.
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