Biomarker Study for Prediction of aGVHD

August 2, 2018 updated by: Jiong HU, Shanghai Jiao Tong University School of Medicine

Biomarker Identification for aGVHD After Allogeneic Stem Cell Transplantation: a Multiple Center Study

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

This is a prospective study, observation study in patients receiving allogeneic stem cell transplantation in 4 BMT centers in Shanghai. The blood samples (on Day-14, -7, 0 and every 7 days until D100) and clinical data will be collected. In the final analysis, a panel of cytokines and biomarkers analysis of serial blood samples will be carried out and compared between patients with no aGVHD and grade II-IV aGVHD.

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Blood & Marrow Transplantation Center, RuiJin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients received allogeneic stem cell transplantation

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • patients with blood sample and clinical data not available

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of grade II-IV aGVHD
Time Frame: 100 days after allogeneic stem cell tansplantation
clinical diagnosis and grade of aGVHD
100 days after allogeneic stem cell tansplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Jiong HU, M.D., Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

July 29, 2018

First Submitted That Met QC Criteria

July 29, 2018

First Posted (Actual)

August 3, 2018

Study Record Updates

Last Update Posted (Actual)

August 6, 2018

Last Update Submitted That Met QC Criteria

August 2, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • SHTG-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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