To hear about similar clinical trials, please enter your email below
Trial Title:
Role of Neutralizing Antibodies in the Prediction and Treatment of BK Virus Infection in Hematopoietic Stem Cell Allograft Patients at the Pediatric Oncology-hematology Department of the HUS
NCT ID:
NCT05618275
Condition:
BK Virus Infection
Conditions: Official terms:
Infections
Communicable Diseases
Virus Diseases
Conditions: Keywords:
BK virus infection
Neutralizing antibodies
Hematopoietic stem cell
Polyomaviridae
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Retrospective
Summary:
The BK virus (BKV) belongs to the Polyomaviridae family. The primary infection, generally
asymptomatic, occurs during childhood. The virus then persists in latent form in the
body, mainly in the epithelial cells of the kidney and urinary tract. Cellular
immunosuppression favors BKV replication. It is responsible for pathologies of the
renal-urinary tract such as BKV-associated nephropathy (BKVAN) in kidney transplant
recipients, hemorrhagic cystitis (HC) in hematopoietic stem cell (HSC) recipients or
ureteral stenosis.
To date, there is no specific antiviral treatment against BKV. The management of patients
is essentially symptomatic and requires a multidisciplinary approach. It is therefore
necessary to identify early prognostic markers for the occurrence of CH and to develop
new therapeutic strategies.
Criteria for eligibility:
Study pop:
HSC allograft patient managed by the pediatric oncology-hematology service of the HUS,
between 01/01/2015 and 31/12/2019
Sampling method:
Non-Probability Sample
Criteria:
Inclusion criteria:
- Adult patient aged 18 to 19 years
- Minor patient (from birth to 17 years old)
- HSC allograft patient managed by the pediatric oncology-hematology service of the
HUS, between 01/01/2015 and 31/12/2019
Exclusion Criteria:
- Opposition of the patient (or parental authority holders) to participate in the
study
- Biological resources from a patient who does not meet all inclusion criteria
- Patient deprived of liberty or under court protection
- Patient under guardianship or curatorship
Gender:
All
Minimum age:
1 Year
Maximum age:
19 Years
Locations:
Facility:
Name:
Service Laboratoire de Virologie - PTM - CHU de Strasbourg - France
Address:
City:
Strasbourg
Zip:
67091
Country:
France
Status:
Recruiting
Contact:
Last name:
Samira FAFI-KREMER, PharmD, PhD
Phone:
33 3 69 55 14 38
Email:
samira.fafi-kremer@chru-strasbourg.fr
Investigator:
Last name:
Samira FAFI-KREMER, PharmD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Catherine PAILLARD, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Aurélie VELAY, MD
Email:
Sub-Investigator
Investigator:
Last name:
François SEVERAC, Statistician
Email:
Sub-Investigator
Start date:
January 1, 2020
Completion date:
December 31, 2022
Lead sponsor:
Agency:
University Hospital, Strasbourg, France
Agency class:
Other
Source:
University Hospital, Strasbourg, France
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05618275
