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

Completed

• 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-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).

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-16
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-06
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2018-04
• Last Update Submitted: 2019-04-24
• Last Update Posted: 2019-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

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.

Trial Locations

Locations (39)

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, District of Columbia, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Cleveland Clinic; 🇺🇸 Weston, Florida, United States

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