Microfluidics and Transcriptomics in Post Solid Organ Transplant Patients

NCT02776111 | Terminated DMC

• 1 other identifier: IRB201600231
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The field of genomics is an exciting new field being applied in medicine. Its use in treating some cancers, sepsis and burn patients has been very promising. As knowledge of genomics and application of microarrays expands, researchers are developing more intelligent ways to provide individualized care for patients. The plan of this research study is to apply the use of genomics as a tool for transplant in several capacities. This research study is designed to develop methods of isolating relevant cell types via microarray plates, then extracting mRNA samples of those cell types and capturing their genetic profile. This will be done with the blood of up to ten healthy donors. Once this ability has been demonstrated, the next step will be to use these testing in several capacities in transplant patients. The research study plan involves following the genetic profile of 26 kidney transplant patients. One group will be followed prospectively starting at baseline, and then at various set time points. A second group will be sampled with the occurrence of clinical events. These events include viral, bacterial, and fungal infection, WBC \< 2.5 or biopsy proven rejection episodes or normal graft function. Thus, the intention of the study is to demonstrate how immunosuppression alters the expression of this genetic expression of these T cells. In doing so, the study will provide a better understanding of the specific and true immunosuppressed state for any given patient.

Conditions

Immunosuppression

Keywords

Kidney Transplant

Outcome Measures

Primary Outcomes (1)

• Genomics of the T-cells will be compared to the immunosuppressed state of kidney transplant patient.

  Standard collected clinical information of patients will identify over, optimal and under immunosuppressive states (IS) in kidney transplant (txp) recipients. In txp care, the definition of IS is defined by the clinical picture of the patient. Patients who have infections are over immunosuppressed, patients who have rejection are under immunosuppressed. Patients with neither and good graft function with normal Cr \& good urine output have optimal IS. The investigators hope to identify a genomic pattern of the mRNA of T cells that correlates with the clinical picture of over, under or optimal IS in a kidney txp patient. Blood will be collected at the time of the events \& genomics will be run on the T cell mRNA from that blood of each type of patient. The specific T cell used (CD3, CD4 or CD8) will be determined by the proof of concept portion of the study. The investigators will update this portion of the study as this information is obtained after the proof of concept is completed.

  12 months

Study Arms (2)

Healthy Controls

Participants in this group will have a one time blood sample taken.

Other: Blood Sample

Kidney Transplant Group

Participants in this group have had a kidney transplant and blood samples will be obtained as described in study plan

Interventions

Blood Sample OTHER

A one time blood sample will be provided.

Healthy Controls

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Controls and Kidney Transplant Patients

You may qualify if:

• Healthy Controls
• consent for blood draw
• Kidney Transplant Group
• actively listed with the University of Florida Kidney Transplant Program (which has its own standards for active listing including not being pregnant),
• consent for blood draw

You may not qualify if:

• Healthy Control
• pregnancy,
• any known organ failure
• Kidney Transplant Group

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

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Biospecimen

Retention: SAMPLES WITH DNA

400 microliters of blood

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ali Zarrinpar, MD, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: May 18, 2016
• Study Start: July 1, 2016
• Primary Completion: June 25, 2019
• Study Completion: June 26, 2019
• Last Updated: July 1, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)