T-SPOT.CMV and T-SPOT.PRT Diagnostic Assays

Completed

Conditions studied: Infection in Solid Organ Transplant Recipients

In brief

The T-SPOT assay quantifies the number of peripheral blood interferon-γ producing effector T cells \[spot forming cells/million peripheral blood mononuclear cells - PBMC)\]. The T-SPOT platform technology can be applied to diagnose and monitor any major disease process driven by a T cell response, including a viral disease such as cytomegalovirus (CMV) infection (the T-SPOT.CMV assay) or an allograft rejection (the T-SPOT.PRT assay).

Key facts

Study ID

NCT02382211

Run by

Oxford Immunotec

People needed

600

Starts

2015-01-01

Expected to finish

2017-09-01

Last updated by the study team

2019-04-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Active candidate or recipient of a kidney transplant. Patients enrolled post-transplant must be within 6 months of transplantation and on active CMV anti-viral prophylaxis.
• Age ≥ 18 years.
• CMV serology of donor and recipient confirmed prior to enrollment. For seronegative subjects (R-), CMV serostatus should be confirmed within eight weeks prior to transplant by the site local laboratory.
• Able to provide T-SPOT pre-transplant samples up to a maximum of one month prior to transplant (in the interval between Day -30 and Day 0), or at the time of enrollment if this occurs following transplantation.
• IRB approved written Informed Consent and privacy language per national regulation (e.g., Health Insurance Portability and Accountability Act for US sites) must be obtained from the subject or legally authorized representative prior to any study related procedures, including screening evaluations and tests.

You may not qualify if…

• Anemia prior to transplant that indicates not a candidate for blood draw.
• On active immunosuppression within two months prior to transplant.
• Multi-organ transplant (dual-kidney allocation is allowed).
• Subject has received prior exposure to a CMV vaccine.
• Subject has undergone or is planning to undergo plasmapheresis.
• Subject requires desensitization for ABO blood type incompatibility or a positive T or B-cell crossmatch.
• Subject is known to be HIV positive.
• Subject is known to have a clinically significant medical or psychiatric condition considered a high risk for participation in an investigational study.

Where it is running

• University of Arizona — Tucson, Arizona, United States
• University of California — Irvine, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Transplant Research Institute — Los Angeles, California, United States
• University of California - San Francisco — San Francisco, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• University of Colorado — Aurora, Colorado, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Tampa General Hospital — Tampa, Florida, United States
• Cleveland Clinic — Weston, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Georgia Regents University — Augusta, Georgia, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• U Maryland — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Washington University — St Louis, Missouri, United States
• U Nebraska — Omaha, Nebraska, United States
• St Barnabas Medical Center — Livingston, New Jersey, United States
• Albany Medical Center — Albany, New York, United States
• Erie County Medical Center — Buffalo, New York, United States
• ICON School of Medicine at Mt Sinai — New York, New York, United States
• SUNY — Syracuse, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Case Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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