PREDICT Cytomegalovirus (CMV)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-31

Study Completion Date

2019-11-25

Brief Summary

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The overall objective of this study is to establish a personalized test to measure individualized cytomegalovirus (CMV) specific immunity in lung transplant recipients in an effort to guide antiviral prophylaxis duration in clinical practice.

Targeted participants are those:

* enrolled in clinical research study CTOT-20 (Clinical Trials.gov ID: NCT02631720) who
* are CMV recipient positive by serology as determined using methods in accordance with current local organ procurement organization policies.

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Detailed Description

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Cytomegalovirus (CMV) is a common virus. The virus is spread from one person to another through infected body fluids. In those with a normal immune system, CMV does not cause much of a problem. The immune system keeps the virus under control so most people do not have any symptoms. Once infected, the virus usually stays dormant (inactive) in the body for a person's entire life. This means some of the cells in the body are infected and the virus can become active again.

Lung transplant recipients take anti-rejection medicines to prevent the body from rejecting the transplanted lung(s). Although anti-rejection medications help protect the transplanted lung(s) from the body's immune system, these medications also decrease the body's ability to fight infections. This reduces the immune system's ability to control viruses like CMV. Many transplant recipients take an antiviral medication early after transplant to help the body control the CMV virus. This is the time that risk of infection would be highest. Sometimes recipients get an active CMV infection after stopping these medicines. If this happens, the infection is treated and monitored.

In this study, investigators are trying to determine whether a blood test can predict development of active CMV infection in lung transplant recipients. Specifically, the clinical research study will prospectively assess the performance of an immune signature based on the "ex vivo" measurement of T cell CMV specific immunity in predicting freedom from future CMV infections among recipient positive (R+) lung transplant participants receiving standard durations of valganciclovir prophylaxis.

Conditions

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Lung Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CMV+ First Lung Transplant Recipients

Participants enrolled in one of four North American sites in clinical research study CTOT-20 (Clinical Trials.gov ID: NCT02631720) who are cytomegalovirus positive by serology (e.g., CMV Recipient positive).

Procedure

Intervention Type OTHER

Serial blood draws. Participants will be enrolled either pre-transplant or within 45 days post-transplant and will be followed over the course of 18 months post transplant. Protocol mandated serial measurement of cytomegalovirus (CMV)-specific immune signature will occur pre-transplant (as applicable) and at post-transplant timepoint months 2, -3, -6, -9, -12 and -18.

Interventions

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Procedure

Serial blood draws. Participants will be enrolled either pre-transplant or within 45 days post-transplant and will be followed over the course of 18 months post transplant. Protocol mandated serial measurement of cytomegalovirus (CMV)-specific immune signature will occur pre-transplant (as applicable) and at post-transplant timepoint months 2, -3, -6, -9, -12 and -18.

Intervention Type OTHER

Other Intervention Names

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Serial blood draws Phlebotomy Venipuncture

Eligibility Criteria

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Inclusion Criteria

Individuals who meet all of the following criteria are eligible for enrollment as study participants:

* Must be able to understand and provide written informed consent;
* Anticipated listing for lung transplantation OR listed for lung transplant OR is within 45 days of having received a single or bilateral cadaveric donor lung transplant;
* Undergoing first lung transplant operation;
* Transplant surgery to be performed or performed at enrolling center;
* Concurrent participation in CTOT-20 (Clinical Trials.gov ID: NCT02631720); and
* CMV-seropositive lung transplant recipient, using methods in accordance with current local organ procurement organization policies.

* Note: Concurrent participation in immune monitoring studies or interventional device trials are permitted.

Exclusion Criteria

Individuals who meet any of the following criteria are not eligible for enrollment as study participants:

* Unwilling to enroll in CTOT-20 (Clinical Trials.gov ID: NCT02631720);
* Multi-organ recipient;
* Prior recipient of any solid organ transplant, including prior lung transplant;
* Prior or concurrent recipient of bone marrow transplant;
* Human Immunodeficiency Virus (HIV) infection;
* Pregnant or planned pregnancy;
* Any condition that, in the investigator's opinion, would make it unlikely for the recipient to complete follow up procedures or complete the study; or
* Participation in an investigational drug trial at the time of enrollment visit.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No