Chemotherapy Efficacy and Follow-up Study of Hepatitis B... | NCT03529760

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

NCT03529760

Sponsor

Children's Hospital of Chongqing Medical University

Status

Unknown status

Last Update Posted

Jul 16, 2019Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Reactivation of Hepatitis B Virus

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 8, 2018Actual

Primary Completion Date

Jul 15, 2019Estimated

Completion Date

May 30, 2020Estimated

First Submitted Date

May 8, 2018

First Submission Date that Met QC Criteria

May 8, 2018

First Posted Date

May 18, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2019

Last Update Posted Date

Jul 16, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Qiu Li, Director, Children's Hospital of Chongqing Medical UniversityPrincipal Investigator

Lead Sponsor

Children's Hospital of Chongqing Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

600Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HBV-DNA positive	Positive HBV nucleic acid test	1-year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The clinical diagnosis of children with leukemia received systemic chemotherapy.

Exclusion Criteria:

Children with non-leukemia and children without appropriate treatment.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

16 Years

Standard Ages

Child

Study Population

1-16-year-old leukemia hospitalized chemotherapy children

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yao Zhao	Contact	86-23-6360-3083		Zhaoy@cqmu.edu.cn

Overall Officials

Name	Affiliation	Role
Yao Zhao	Chongqing Children's Hospital of Chongqing Medical University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chongqing Children's Hospital of Chongqing Medical University	Recruiting	Chongqing	Chongqing Municipality	400014	China

Condition Browse Module

MeSH Terms

ID	Term
D007938	Leukemia

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided