Cytokine Assay for Early Identification of Pediatric Stem Cell Transplant Recipients

April 7, 2023 updated by: Rajni Agarwal, Stanford University

Cytokine Assay for Early Identification of Pediatric Stem Cell Transplant Recipients at Risk for Respiratory Failure

The aim of our study is to determine whether a clinically relevant laboratory measurement (of seven specific immunologic biochemicals in the blood) can identify which bone marrow transplant recipients are likely to progress to respiratory failure. Our ultimate goal is to devise a comprehensive and inclusive laboratory test that is effective at determining who is likely to go on to respiratory failure, in order to facilitate early medical intervention.

Study Overview

Status

Terminated

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

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

Study Contact

Study Locations

    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

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

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Hematopoietic stem cell transplantation (HSCT) for any indication.

Description

Inclusion Criteria:- Hematopoietic stem cell transplantation (HSCT) for any indication.

  • Patients will range from age 0 to age 21. There is no gender restriction. We expect the male to female ratio to end up being about 50/50
  • Ability to understand and the willingness to sign a written informed consent document.

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
Time Frame
Compute median flourescence intensity, standard curves, and estimated pg/mL for each cytokine.
Time Frame: weekly during hospitalization for transplant
weekly during hospitalization for transplant

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Rajni Agarwal-Hashmi, Stanford University

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

July 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

June 1, 2010

First Submitted That Met QC Criteria

June 1, 2010

First Posted (Estimate)

June 2, 2010

Study Record Updates

Last Update Posted (Actual)

April 10, 2023

Last Update Submitted That Met QC Criteria

April 7, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • PEDSBMT199
  • SU-09222008-1301 (Other Identifier: Stanford University)
  • PEDSHSCT0002 (Other Identifier: Stanford University - Previous OnCore ID)
  • 14862 (Other Identifier: stanford IRB)

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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