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

NCT02382211 | Completed

• 1 other identifier: US OI 124
• Study Type: observational
• Target: 600
• Locations: 3 countries
• Sites: 39

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).

Conditions

Infection in Solid Organ Transplant Recipients

Keywords

CMV

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Active candidate for a kidney transplant. Age equal to or greater than 18 years. Male or female.

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.

Sponsors & Collaborators

• Oxford Immunotec: lead

Study Sites (39)

University of Arizona

Tucson, Arizona, 85721, United States

Location

University of California

Irvine, California, 92868, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Transplant Research Institute

Los Angeles, California, 90057, United States

Location

University of California - San Francisco

San Francisco, California, 94143, United States

Location

California Pacific Medical Center

San Francisco, California, 94415, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Cleveland Clinic

Weston, Florida, 33331, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Georgia Regents University

Augusta, Georgia, 30912, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70130, United States

Location

U Maryland

Baltimore, Maryland, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02144, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

U Nebraska

Omaha, Nebraska, United States

Location

St Barnabas Medical Center

Livingston, New Jersey, United States

Location

Albany Medical Center

Albany, New York, United States

Location

Erie County Medical Center

Buffalo, New York, 14215, United States

Location

ICON School of Medicine at Mt Sinai

New York, New York, 10029, United States

Location

SUNY

Syracuse, New York, 13210, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Case Medical Center

Cleveland, Ohio, 44106, United States

Location

University of Toledo Medical Center

Toledo, Ohio, United States

Location

Legacy Transplant Services

Portland, Oregon, 92710, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Baylor All Saints Medical Center

Fort Worth, Texas, 76104, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Baylor College of Medicine

Houston, Texas, United States

Location

Intermoutain Health Care

Salt Lake City, Utah, 84107, United States

Location

University of Washington

Seattle, Washington, 98122, United States

Location

Providence Health and Services

Spokane, Washington, 99204, United States

Location

University Health Network

Toronto, Ontario, m5g 2n2, Canada

Location

Queen Elizabeth Hospital

Birmingham, United Kingdom

Location

Guy's Hospital

London, United Kingdom

Location

Churchill Hospital

Oxford, United Kingdom

Location

Study Design

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

Study Record Dates

• First Submitted: February 16, 2015
• First Posted: March 6, 2015
• Study Start: January 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 25, 2019

Record last verified: 2018-04

Locations

CA (1); GB (3); US (35)