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Chemotherapy Efficacy and Follow-up Study of Hepatitis B Virus Infection and Reactivation in Children With Leukemia

Sponsor
Children's Hospital of Chongqing Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03529760
Collaborator
(none)
600
Enrollment
1
Location
24.7
Anticipated Duration (Months)
24.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Children with clinically diagnosed leukemia may experience occult HBV infection after chemotherapy immunosuppressive therapy, which may affect the normal course of leukemia treatment. However, this is not caused by clinically relevant diagnosis and treatment measures but exists in vivo.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The clinical diagnosis of children with leukemia may be due to the influence of leukemia disease on the immune cells of the children and the damage to the immune system due to immunosuppressive therapy in children. Therefore, the risk of contracting hepatitis B virus is relatively high, and some children are In the treatment of immunosuppressive chemotherapy (later), the reactivation of occult HBV infection has an impact on the normal course of leukemia treatment. However, this is not a clinically relevant diagnosis and treatment measure. It is necessary to avoid unnecessary conflicts between clinical doctors and patients as much as possible.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Chemotherapy Efficacy and Follow-up Study of Hepatitis B Virus Infection and Reactivation in Children With Leukemia
    Actual Study Start Date :
    May 8, 2018
    Anticipated Primary Completion Date :
    Jul 15, 2019
    Anticipated Study Completion Date :
    May 30, 2020

    Outcome Measures

    Primary Outcome Measures

    1. HBV-DNA positive [1-year]

      Positive HBV nucleic acid test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    The clinical diagnosis of children with leukemia received systemic chemotherapy.

    Exclusion Criteria:

    Children with non-leukemia and children without appropriate treatment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chongqing Children's Hospital of Chongqing Medical University Chongqing Chongqing China 400014

    Sponsors and Collaborators

    • Children's Hospital of Chongqing Medical University

    Investigators

    • Study Director: Yao Zhao, Chongqing Children's Hospital of Chongqing Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qiu Li, Director, Children's Hospital of Chongqing Medical University
    ClinicalTrials.gov Identifier:
    NCT03529760
    Other Study ID Numbers:
    • 2018-27
    First Posted:
    May 18, 2018
    Last Update Posted:
    Jul 16, 2019
    Last Verified:
    Jul 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Qiu Li, Director, Children's Hospital of Chongqing Medical University
    Leukemia, occult hepatitis B virus infection
    Additional relevant MeSH terms:
    Infections
    Hepatitis A
    Virus Diseases
    Hepatitis B
    Herpesviridae Infections
    Leukemia
    Hepatitis

    Study Results

    No Results Posted as of Jul 16, 2019