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NCT02398708 · ClinicalTrials.gov registry record
Comparison of Gut Microbiota, Inflammation and Symptoms Following Allogeneic HSCT
A clinical trial of Graft-Versus-Host Disease and Graft Vs Host Disease, sponsored by University of Florida.
- Completed
- Registry status
- 38
- Enrollment target
- 1
- Study location
NCT02398708: Completed study of Graft-Versus-Host Disease and Graft Vs Host Disease, sponsored by University of Florida.
NCT02398708 is a study of Graft-Versus-Host Disease and Graft Vs Host Disease that has completed, run by University of Florida. The registered enrollment target is 38 participants, below the 82-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02398708, a study of Graft-Versus-Host Disease and Graft Vs Host Disease, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to examine the gut bacteria, levels of peripheral blood inflammation markers, and symptoms in patients with and without chronic graft-versus-host disease (cGVHD) following allogeneic hematopoietic stem cell transplant (allo-HSCT). The hypothesis is that individuals with cGVHD will have lower levels of microbial diversity, higher levels of inflammatory metabolites in stool and peripheral measures, and higher levels of symptoms than individuals without cGVHD.
Primary Outcome
Cytokines will be analyzed using a multiplex assay by Millipore Company. Compared to the traditional enzyme-linked immunosorbant assays (ELISA), the multiplex is comparable and more sensitive to lower concentration levels of cytokines than the ELISA. One laser identifies a specific bead and another laser identifies the reported antibody associated with the bead-bound cytokine. One hundred beads for each of the 17 cytokines in every sample are assayed and a mean cytokine binding for the sample is
Conditions Studied
Interventions
- OTHER Questionnaires
- OTHER Blood Sample
- OTHER Stool Sample
- OTHER Clinical data
Study Locations (1)
Florida
- UF Health Cancer Hospital - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2015-05 |
| Est. Completion | 2016-04 |
What the finished NCT02398708 record still lists
NCT02398708 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 82-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (54% lower).
The record links to 4 conditions, with Graft-Versus-Host Disease appearing as the primary indexed condition, and to 4 interventions - of which Questionnaires is the first listed.
NCT02398708 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT02398708 about?
NCT02398708 is a clinical study titled "Comparison of Gut Microbiota, Inflammation and Symptoms Following Allogeneic HSCT". The purpose of this study is to examine the gut bacteria, levels of peripheral blood inflammation markers, and symptoms in patients with and without chronic graft-versus-host disease (cGVHD) following allogeneic hematopoietic stem cell transplant (allo-HSCT). The hypothesis is that individuals with ...
What is the current status of trial NCT02398708?
This trial is currently completed. The enrollment target is 38 participants. The study started on 2015-05. Estimated completion is 2016-04.
What conditions does trial NCT02398708 study?
This clinical trial studies the following conditions: Graft-Versus-Host Disease, Graft Vs Host Disease, Hematopoietic Stem Cell Transplantation, Peripheral Blood Stem Cell Transplantation.
What interventions are being tested in trial NCT02398708?
The interventions under investigation include: Questionnaires (OTHER), Blood Sample (OTHER), Stool Sample (OTHER), Clinical data (OTHER).
Who is sponsoring clinical trial NCT02398708?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02398708 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02398708's enrollment target sits among peer trials
38 20th of 38 higher than 17 of 38 other Graft-Versus-Host Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Graft-Versus-Host Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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