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



Status:Recruiting
Healthy:No
Age Range:18 - 75
Updated:6/22/2016
Start Date:January 2015
End Date:January 2018
Contact:Study Manager
Email:tblanchard@oxfordimmunotec.com
Phone:508-281-6108

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A Prospective Observational Trial to Evaluate the Correlation of T-SPOT® Response to CMV Infection and T Cell-mediated Acute Graft Rejection

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).

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.

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.
We found this trial at
31
sites
Livingston, New Jersey 07039
Principal Investigator: Anup Patel, MD
Phone: 973-422-9623
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Aneesh Mehta, MD
Phone: 404-712-1737
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: David Wojciechowski, MD
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Boston, MA
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Michelle Lieberman, MD
Phone: 347-671-8216
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Principal Investigator: Bernard Fischbach, MD
Phone: 214-820-6243
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Ajit Limaye, MD
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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1 Brookings Drive
St. Louis, Missouri 63110
 (314) 935-5000
Principal Investigator: Daniel Brennan, MD
Phone: 314-362-4109
Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Principal Investigator: Rajendera Baliga, MD
Phone: 813-844-5692
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Weston, Florida 33331
Principal Investigator: Neerja Agrawal, MD
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1120 15th Street
Augusta, Georgia 30912
(706) 721-0211
Principal Investigator: Carlos Zayas, MD
Georgia Regents University Georgia Regents University, home of the Medical College of Georgia, is one...
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Aurora, Colorado 80045
Principal Investigator: Alexander Wiseman, MD
Phone: 303-724-0183
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Buffalo, New York 14215
Principal Investigator: Liise Kayler, MD
Phone: 716-898-3418
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Kenneth Chavin, MD
Phone: 843-792-8824
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Keith Luckett, MD
Phone: 513-558-0046
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cleveland, Ohio 44106
Principal Investigator: Donald Hricik, MD
Phone: 216-844-5396
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Fort Worth, Texas 76104
Principal Investigator: Bernard Fischbach, MD
Phone: 817-922-2585
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Houston, Texas 77030
Principal Investigator: Osama Gaber, MD
Phone: 713-441-6394
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Irvine, California 92697
Principal Investigator: Hirohito Ichii, MD
Phone: 714-456-6015
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Principal Investigator: Arputharaj Kore, MD
Phone: 909-558-3672
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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Los Angeles, California 90057
Principal Investigator: Robert Naraghi, MD
Phone: 714-548-4372
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New Orleans, Louisiana 70121
Principal Investigator: Ari Cohen, MD
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New York, New York 10029
Principal Investigator: Shirish Huprikar, MD
Phone: 212-241-0255
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Portland, Oregon 97210
Principal Investigator: William Bennett, MD
Phone: 503-413-7437
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Salt Lake City, Utah 84107
Principal Investigator: Michael Charlton, MD
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San Francisco, California 94143
Principal Investigator: Peter Chin-Hong, MD
Phone: 415-476-4862
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45 Castro Street
San Francisco, California 94114
(415) 600-6000
Principal Investigator: V. Ram Peddi, MD
Phone: 415-600-1627
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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Spokane, Washington 99204
Principal Investigator: Okechukwu Ojogho, MD
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Syracuse, New York 13210
Principal Investigator: Mark Laftavi, MD
Phone: 315-464-1852
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Toronto, Ontario
Principal Investigator: Deepali Kumar, MD
Phone: 416-340-4800
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Tucson, Arizona 85721
(520) 621-2211
Principal Investigator: Pradeep Kadambi, MD
Phone: 520-626-7114
University of Arizona The University of Arizona is a premier, public research university. Established in...
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3700 O Street Northwest
Washington, DC, District of Columbia 20007
Principal Investigator: Matthew Cooper, MD
Phone: 202-444-5695
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