- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01135355
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
Conditions
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
- Name: Kimberly Boynton
- Phone Number: (650) 498-6713
- Email: boynton@stanford.edu
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University School of Medicine
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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
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weekly during hospitalization for transplant
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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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