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

NCT ID: NCT02382211

Last Updated: 2019-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-09-30

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.

Conditions

Infection in Solid Organ Transplant Recipients

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oxford Immunotec

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

University of Toledo Medical Center

Toledo, Ohio, United States

Legacy Transplant Services

Portland, Oregon, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Baylor University Medical Center

Dallas, Texas, United States

Baylor All Saints Medical Center

Fort Worth, Texas, United States

Houston Methodist

Houston, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Intermoutain Health Care

Salt Lake City, Utah, United States

University of Washington

Seattle, Washington, United States

Providence Health and Services

Spokane, Washington, United States

University Health Network

Toronto, Ontario, Canada

Queen Elizabeth Hospital

Birmingham, , United Kingdom

Guy's Hospital

London, , United Kingdom

Churchill Hospital

Oxford, , United Kingdom

Countries

United States; Canada; United Kingdom

Other Identifiers

US OI 124

Identifier Type: -

Identifier Source: org_study_id