Donor Neutrophil Subsets to Predict the Risk of aGVHD | NCT06394895

Studies
Donor Neutrophil Subsets to Predict the Risk of aGVHD

NCT06394895

Sponsor

Nanfang Hospital, Southern Medical University

Status

Unknown status

Last Update Posted

May 1, 2024Actual

Enrollment

260Estimated

Phase

Not provided

Conditions

Acute Graft-versus-Host Disease

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

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Actual

Primary Completion Date

Feb 29, 2024Actual

Completion Date

Jun 10, 2024Estimated

First Submitted Date

Dec 20, 2023

First Submission Date that Met QC Criteria

Apr 28, 2024

First Posted Date

May 1, 2024Actual

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

Apr 28, 2024

Last Update Posted Date

May 1, 2024Actual

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

This is a prospective study to explore the association between donor neutrophil subsets and acute graft-vs.-host disease outcomes. Approximately 260 subjects (including 130 donors and 130 corresponding recipients) will be recruited.

Detailed Description

This study was a single-center, observational, prospective cohort study. The study lasted for 3 months, from 2023.12 to 2024.3, the clinical enrollment was completed, and from 2024.3 to 2024.6, the follow-up was completed. It is planned to enroll 260 subjects, divided into 130 donors and 130 patients.

No randomization or any protocol-driven treatment will be performed or provided to subjects during the course of the study. Treatment decisions and selection of treatment options are left to the discretion of the treating physician, if clinically appropriate.

All recipients will be followed for aGVHD evaluation, relapse, cGVHD, leukemia relapse, disease-free survival (DFS), non-relapse mortality (NRM). aGVHD and cGVHD were graded according to published guidelines. All recipients will be monitored every month until the study is completed.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

100 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

260Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Association between donor neutrophil subsets and acute graft-vs.-host disease (aGVHD) outcomes.		100days

Secondary Outcomes

Measure	Description	Time Frame
Association between donor neutrophil subsets and chronic GVHD (cGVHD)		6 months
Association between donor neutrophil subsets and leukemia relapse		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Donors

Voluntarily sign the informed consent form;
Age 16-65 years old
Donors whose HLA-matched or HLA-mismatched to the corresponding recipients

Recipients

Voluntarily sign the informed consent form
Age 16-65 years old
Willing to undergo HLA-matched or HLA-mismatched allo-HSCT

Exclusion Criteria:

Donors

Have a history of other tumors
With poor compliance or mental disorders
Infected with HIV and HCV
With uncontrolled HBV infection
With other autoimmune diseases
Those who are judged by the researcher to be unsuitable to participate in this study

Recipients

Have a history of other tumors
With poor compliance or mental disorders
Infected with HIV and HCV
With uncontrolled HBV infection
With other autoimmune diseases
Those who are judged by the researcher to be unsuitable to participate in this study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients following allogeneic hematopoietic stem cell transplantation and the corresponding donors

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hua Jin	Nanfang Hospital, Southern Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanfang Hospital, Southern Medical University		Guangzhou	Other (Non U.s.)	510000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Label	Type	Description	Intervention Names
Subject-recipient (high incidence /low incidence group)
Subject-donor