NCT03614143

Brief Summary

This is a prospective study in patients receiving allogeneic stem cell transplantation. The blood samples on Day-14, -7, 0 and every 7 days until D100 were collected together with clinical data. In the final analysis, cytokines and biomarkers analysis will be carried out and compared between patients in No aGVHD and grade II-IV aGVHD.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

August 6, 2018

Status Verified

August 1, 2018

Enrollment Period

3 years

First QC Date

July 29, 2018

Last Update Submit

August 2, 2018

Conditions

aGVHD

Outcome Measures

Primary Outcomes (1)

  • incidence of grade II-IV aGVHD

    clinical diagnosis and grade of aGVHD

    100 days after allogeneic stem cell tansplantation

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients received allogeneic stem cell transplantation

You may qualify if:

  • all patients undergoing allogeneic stem cel transplantation
  • with informed consent
  • patients survived without aGVHD or relapse and patients with development of grade II-IV aGVHD

You may not qualify if:

  • patients with blood sample and clinical data not available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blood & Marrow Transplantation Center, RuiJin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

Study Officials

  • Jiong HU, M.D.

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiong HU, M.D.

CONTACT

86-21-64370045hj10709@rjh.com.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy director, department of hematology, Rui Jin Hospital

Study Record Dates

First Submitted

July 29, 2018

First Posted

August 3, 2018

Study Start

December 1, 2016

Primary Completion

December 1, 2019

Study Completion

July 1, 2020

Last Updated

August 6, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)