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

Last Updated: 2022-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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BK Virus Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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

* Patient deprived of liberty or under court protection
* Patient under guardianship or curatorship

Exclusion Criteria

* Opposition of the patient (or parental authority holders) to participate in the study
Minimum Eligible Age

1 Year

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service Laboratoire de Virologie - PTM - CHU de Strasbourg - France

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Samira FAFI-KREMER, PharmD

Role: CONTACT

33 3 69 55 14 38

Facility Contacts

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Samira FAFI-KREMER, PharmD, PhD

Role: primary

33 3 69 55 14 38

Other Identifiers

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7635

Identifier Type: -

Identifier Source: org_study_id

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