- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02917148
MicroRNAs as Diagnostic and Predictive Biomarkers for Acute Graft Versus Host Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Human subjects that volunteer to participate in this study will be requested to have approximately 20 cc of blood drawn (about 12 tablespoons) at several time intervals. These time intervals include prior to conditioning regimen for transplant, the day of transplantation, day +30, +60 and +100 after transplantation. If a given subject develops acute graft-versus-host disease, a blood sample will be obtained at that time as well. The amount of blood samples collected in an 8 week period will not exceed 50 ml and collection will not occur more than twice a week. There will be no pregnant women or children involved in the investigators study.
All patients involved in the study will be undergoing bone marrow transplant and pregnancy screening is done in pre-transplant testing. This blood will be collected in lavender top, EDTA tubes; some plasma (or serum) may be collected and stored for additional analysis.
Study Type
Contacts and Locations
Study Locations
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New York
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Lake Success, New York, United States, 11042
- Monter Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients undergoing fully matched allogeneic PBCSC and bone marrow transplantation who present with clinical signs and symptoms of grade II- IV aGVHD within 100 days after transplantation as defined by skin, GI, and/or liver involvement that are confirmed by biopsy, regardless of age
- Patients undergoing a matched, unrelated donor (8/8) or matched, related donor transplant (6/6)
- Allogeneic transplant is from donor's peripheral blood stem cells or bone marrow transplant
- Patients who develop grade II-IV aGVHD
Exclusion Criteria:
- Patients who receive transplants from incompletely matched donors
- Patients who receive T cell depleted transplants
- Patients who receive haplo-identical transplants
- Pregnant Patients
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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aGVHD
Patient who undergo allogeneic transplant with clinical and/or biopsy-proven diagnosis of aGVHD within the first 100 days post-transplant.
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Other Names:
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non aGVHD
Patients who undergo allogeneic transplant but do not develop aGVHD.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Identify plasma microRNA expression in stem cell transplant patients with acute graft versus host disease compared to controls.
Time Frame: 24 months
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24 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cheryl Mensah, MD, Northwell Health
Publications and helpful links
General Publications
- Ferrara JL, Levine JE, Reddy P, Holler E. Graft-versus-host disease. Lancet. 2009 May 2;373(9674):1550-61. doi: 10.1016/S0140-6736(09)60237-3. Epub 2009 Mar 11.
- Paczesny S. Discovery and validation of graft-versus-host disease biomarkers. Blood. 2013 Jan 24;121(4):585-94. doi: 10.1182/blood-2012-08-355990. Epub 2012 Nov 19.
- Xiao B, Wang Y, Li W, Baker M, Guo J, Corbet K, Tsalik EL, Li QJ, Palmer SM, Woods CW, Li Z, Chao NJ, He YW. Plasma microRNA signature as a noninvasive biomarker for acute graft-versus-host disease. Blood. 2013 Nov 7;122(19):3365-75. doi: 10.1182/blood-2013-06-510586. Epub 2013 Sep 16.
- Xie LN, Zhou F, Liu XM, Fang Y, Yu Z, Song NX, Kong FS. Serum microRNA155 is increased in patients with acute graft-versus-host disease. Clin Transplant. 2014 Mar;28(3):314-23. doi: 10.1111/ctr.12314. Epub 2014 Feb 4.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-229
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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