T-SPOT.CMV and T-SPOT.PRT Diagnostic Assays
- Conditions
- Infection in Solid Organ Transplant Recipients
- Registration Number
- NCT02382211
- Lead Sponsor
- Oxford Immunotec
- Brief Summary
The T-SPOT assay quantifies the number of peripheral blood interferon-ฮณ 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).
- Detailed Description
Approximately 600 subjects who meet inclusion/exclusion criteria will be enrolled in the prospective, non-randomized, observational study. Sample size is based on having an adequate overall number of subjects to assess the T-SPOT.PRT endpoint (350) and the T-SPOT.CMV endpoint (250) in the defined populations. Subjects may be enrolled from pre-transplantation to post-transplantation up to completion of antiviral prophylaxis.
Study duration: 37 months; 25 months to enroll all subjects with 12 months (365 days) of patient participation.
Study population:
All subjects enrolled in this study will be men or women, aged 18 years or older and recipients of a first or subsequent renal transplant.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of anti-CMV cell-mediated immunity using the change in T-SPOT counts Change in T-SPOT counts from baseline to 365 days post transplant.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (39)
Transplant Research Institute
๐บ๐ธLos Angeles, California, United States
Emory University
๐บ๐ธAtlanta, Georgia, United States
Churchill Hospital
๐ฌ๐งOxford, United Kingdom
Washington University
๐บ๐ธSaint Louis, Missouri, United States
ICON School of Medicine at Mt Sinai
๐บ๐ธNew York, New York, United States
Loma Linda University Medical Center
๐บ๐ธLoma Linda, California, United States
U Maryland
๐บ๐ธBaltimore, Maryland, United States
Cleveland Clinic
๐บ๐ธWeston, Florida, United States
Case Medical Center
๐บ๐ธCleveland, Ohio, United States
University of California
๐บ๐ธIrvine, California, United States
Queen Elizabeth Hospital
๐ฌ๐งBirmingham, United Kingdom
Providence Health and Services
๐บ๐ธSpokane, Washington, United States
University of Arizona
๐บ๐ธTucson, Arizona, United States
Georgia Regents University
๐บ๐ธAugusta, Georgia, United States
Georgetown University
๐บ๐ธWashington, District of Columbia, United States
Albany Medical Center
๐บ๐ธAlbany, New York, United States
University of Toledo Medical Center
๐บ๐ธToledo, Ohio, United States
Baylor All Saints Medical Center
๐บ๐ธFort Worth, Texas, United States
St Barnabas Medical Center
๐บ๐ธLivingston, New Jersey, United States
Massachusetts General Hospital
๐บ๐ธBoston, Massachusetts, United States
University Health Network
๐จ๐ฆToronto, Ontario, Canada
Baylor University Medical Center
๐บ๐ธDallas, Texas, United States
University of Washington
๐บ๐ธSeattle, Washington, United States
University of California - San Francisco
๐บ๐ธSan Francisco, California, United States
California Pacific Medical Center
๐บ๐ธSan Francisco, California, United States
University of Colorado
๐บ๐ธAurora, Colorado, United States
Tampa General Hospital
๐บ๐ธTampa, Florida, United States
U Nebraska
๐บ๐ธOmaha, Nebraska, United States
University of Cincinnati
๐บ๐ธCincinnati, Ohio, United States
Legacy Transplant Services
๐บ๐ธPortland, Oregon, United States
Intermoutain Health Care
๐บ๐ธSalt Lake City, Utah, United States
Houston Methodist
๐บ๐ธHouston, Texas, United States
Baylor College of Medicine
๐บ๐ธHouston, Texas, United States
Erie County Medical Center
๐บ๐ธBuffalo, New York, United States
SUNY
๐บ๐ธSyracuse, New York, United States
Medical University of South Carolina
๐บ๐ธCharleston, South Carolina, United States
Ochsner Clinic Foundation
๐บ๐ธNew Orleans, Louisiana, United States
Montefiore Medical Center
๐บ๐ธBronx, New York, United States
Guy's Hospital
๐ฌ๐งLondon, United Kingdom