Markers of Inflammation in Hematopoietic Stem Cell Transplant
1 other identifier
observational
30
1 country
1
Brief Summary
Objectives:
- 1.To show feasibility and reproducibility of performing a multiplex ligation-dependent amplification procedure (RT-MLPA)
- 2.To describe the profile of changes in inflammatory gene products, using RT-MLPA, in pediatric patients receiving stem cell transplant
- 3.To determine if changes in a specific inflammatory product, or a combination of inflammatory products, can predict grade 2-4 acute graft-versus-host disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 21, 2007
CompletedFirst Posted
Study publicly available on registry
December 24, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2012
CompletedAugust 30, 2019
August 1, 2019
1.5 years
December 21, 2007
August 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To show feasibility and reproducibility of performing a multiplex ligation-dependent amplification procedure (RT-MLPA)
Until September 2008
Secondary Outcomes (2)
To describe the profile of changes in inflammatory gene products, using RT-MLPA, in pediatric patients receiving stem cell transplant
Until September 2008
To determine if change in a specific inflammatory product, or a combination of inflammatory products, can predict grade 2-4 acute graft-versus-host disease
Until September 2008
Study Arms (2)
1
For Objective #1: * Healthy adult volunteers
2
For Objectives #2 \& #3: * Recipients undergoing an allogeneic stem cell transplant
Eligibility Criteria
Patients undergoing a hematopoietic stem cell transplant at Children's Memorial Hospital
You may qualify if:
- Objective #1:
- Healthy adult volunteers, affiliated to Children's Memorial Hospital
- Male or female
- Objective #2 \& #3:
- Recipient undergoing an allogeneic stem cell transplant
- Receiving related or unrelated cord blood, related or unrelated bone marrow or peripheral blood stem cells
- Any pre-transplant regimen
- Ages of 0-21 years old
- Male or female
You may not qualify if:
- Inability for subject/parent to understand study and therefore unable to consent
- Children under 7.0 kgs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lurie Children's Hospital
Chicago, Illinois, 60611, United States
Biospecimen
2.5 mL's of whole blood are obtained one time a week for the first 100 days of transplant
Study Officials
- PRINCIPAL INVESTIGATOR
Reggie Duerst, MD
Ann & Robert H Lurie Children's Hospital of Chicago
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Director - Stem Cell Transplant
Study Record Dates
First Submitted
December 21, 2007
First Posted
December 24, 2007
Study Start
April 1, 2007
Primary Completion
October 1, 2008
Study Completion
December 12, 2012
Last Updated
August 30, 2019
Record last verified: 2019-08