Infection in Solid Organ Transplant RecipientsPROTECTNCT02382211
T-SPOT.CMV and T-SPOT.PRT Diagnostic Assays
An observational study of Infection in Solid Organ Transplant Recipients, run by Oxford Immunotec at 39 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Infection in Solid Organ Transplant Recipients
- How many people
- 600 participants
- Where
- 39 sitesin 3 countries
- Study dates
- Jan 2015to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Active candidate for a kidney transplant. Age equal to or greater than 18 years. Male or female.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
39 sites in 3 countries.
39 sites in 3 countries
United States35 sites
Albany Medical Center
Albany, New York
Emory University
Atlanta, Georgia, 30322
Georgia Regents University
Augusta, Georgia, 30912
University of Colorado
Aurora, Colorado, 80045
U Maryland
Baltimore, Maryland
Massachusetts General Hospital
Boston, Massachusetts, 02144
Erie County Medical Center
Buffalo, New York, 14215
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Cincinnati
Cincinnati, Ohio, 45219
Case Medical Center
Cleveland, Ohio, 44106
Baylor University Medical Center
Dallas, Texas, 75246
Baylor All Saints Medical Center
Fort Worth, Texas, 76104
Houston Methodist
Houston, Texas, 77030
Baylor College of Medicine
Houston, Texas
University of California
Irvine, California, 92868
St Barnabas Medical Center
Livingston, New Jersey
Loma Linda University Medical Center
Loma Linda, California, 92354
Transplant Research Institute
Los Angeles, California, 90057
Ochsner Clinic Foundation
New Orleans, Louisiana, 70130
ICON School of Medicine at Mt Sinai
New York, New York, 10029
U Nebraska
Omaha, Nebraska
Legacy Transplant Services
Portland, Oregon, 92710
Intermoutain Health Care
Salt Lake City, Utah, 84107
University of California - San Francisco
San Francisco, California, 94143
California Pacific Medical Center
San Francisco, California, 94415
University of Washington
Seattle, Washington, 98122
Providence Health and Services
Spokane, Washington, 99204
Washington University
St Louis, Missouri, 63110
SUNY
Syracuse, New York, 13210
Tampa General Hospital
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
University of Toledo Medical Center
Toledo, Ohio
University of Arizona
Tucson, Arizona, 85721
Georgetown University
Washington D.C., District of Columbia, 20007
Cleveland Clinic
Weston, Florida, 33331
United Kingdom3 sites
Queen Elizabeth Hospital
Birmingham
Guy's Hospital
London
Churchill Hospital
Oxford
About this study
Official title: 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).
Read the 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.
- Keywords
- CMV
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of anti-CMV cell-mediated immunity using the change in T-SPOT counts
Measured: Change in T-SPOT counts from baseline to 365 days post transplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection in Solid Organ Transplant RecipientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford Immunotec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382211
- Sponsor's protocol ID
- US OI 124
- Acronym
- PROTECT
- Status last verified
- Apr 2018
- First submitted
- 16 Feb 2015
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Trial to Evaluate the Correlation of T-SPOT® Response to CMV Infection and T Cell-mediated Acute Graft Rejection
- ClinicalTrials.gov ID
- NCT02382211
- Acronym / sponsor ID
- PROTECT / US OI 124
- Keywords
- CMV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Oxford ImmunotecIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 6 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Active candidate for a kidney transplant. Age equal to or greater than 18 years. Male or female.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of anti-CMV cell-mediated immunity using the change in T-SPOT counts
Time frame: Change in T-SPOT counts from baseline to 365 days post transplant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
39 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection in Solid Organ Transplant Recipients, run by Oxford Immunotec at 39 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, United Kingdom, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of anti-CMV cell-mediated immunity using the change in T-SPOT counts (time frame: Change in T-SPOT counts from baseline to 365 days post transplant.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.