Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02876146 |
| Other study ID # |
R/2011/41 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2012 |
| Est. completion date |
August 2021 |
Study information
| Verified date |
October 2017 |
| Source |
Centre Hospitalier Universitaire de Besancon |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Study design to define improved management of patients with hepatic alveolar echinococcosis
treated with albendazole and especially make appropriate and timely decision of treatment
withdrawal .
Based on exploratory analysis of existing and newly developed biological and imaging exams,
for diagnosis and follow-up, and study of the relationship of these markers to the viability
of the parasite and/or the activity of the parasitic lesions The study included two series of
patients: operated on (curative hepatectomy) // non-operated on
Description:
Close follow-up of the patients, based on WHO guidelines (Brunetti, Acta tropica 2010),
including albendazole bloods levels determination.
Clinical exam, sampling and storing (biobank) of blood specimens at inclusion, M1, M3, M6,
M9, M12, M18, M24, M30, M36, M44, M48.
Additional sampling for operated on patients : M15 and M21.
Imaging each year (US, CT, PET-CT & RMI).
Preservation of operative specimens samples at -80°C: samples taken at different location
(center and periphery of the lesions) and in distant non-infected liver, for further studies
of the immune response, RNA detection, and albendazole dosages.
