Clinical trial NCT02382211: T-SPOT.CMV and T-SPOT.PRT Diagnostic Assays
Official title: A Prospective Observational Trial to Evaluate the Correlation of T-SPOT® Response to CMV Infection and T Cell-mediated Acute Graft Rejection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection in Solid Organ Transplant Recipients
Keywords: CMV
Lead sponsor: Oxford Immunotec
Sponsor class: INDUSTRY
First posted: 2015-03-06
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Active candidate for a kidney transplant. Age equal to or greater than 18 years.

Male or female.

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.

Eligibility criteria: Inclusion criteria:

1. 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.
2. Age ≥ 18 years.
3. 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.
4. 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.
5. 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.

Exclusion criteria:

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

Primary outcomes:
measure: Assessment of anti-CMV cell-mediated immunity using the change in T-SPOT counts
timeFrame: Change in T-SPOT counts from baseline to 365 days post transplant.
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Irvine
country: United States
facility: University of California
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Los Angeles
country: United States
facility: Transplant Research Institute
state: California
city: San Francisco
country: United States
facility: University of California - San Francisco
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: U Maryland
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Omaha
country: United States
facility: U Nebraska
state: Nebraska
city: Livingston
country: United States
facility: St Barnabas Medical Center
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
city: New York
country: United States
facility: ICON School of Medicine at Mt Sinai
state: New York
city: Syracuse
country: United States
facility: SUNY
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Case Medical Center
state: Ohio
city: Toledo
country: United States
facility: University of Toledo Medical Center
state: Ohio
city: Portland
country: United States
facility: Legacy Transplant Services
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Baylor All Saints Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Salt Lake City
country: United States
facility: Intermoutain Health Care
state: Utah
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Spokane
country: United States
facility: Providence Health and Services
state: Washington
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: London
country: United Kingdom
facility: Guy's Hospital
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
References: