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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ddPCR | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ddPCR sensitivity by cyst stage | Number of subjects with cfDNA of E. granulosus s.l. detected by ddPCR in plasma, in ratio to the total number of subjects with certain diagnosis of hepatic cystic echinococcosis not treated divided by the presence of active and inactive cysts. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elvia Malo | Contact | +390456014854 | ricerca.clinica@sacrocuore.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Fondazione Policlinico San Matteo | Recruiting | Pavia | PV | Italy |
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| ID | Term |
|---|---|
| D004443 | Echinococcosis |
| ID | Term |
|---|---|
| D002590 | Cestode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| IRCCS Sacro Cuore Don Calabria hospital | Recruiting | Negrar | Verona | 37024 | Italy |
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