PREDICT Cytomegalovirus (CMV) (PREDICT CMV)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03300882|
Recruitment Status : Recruiting
First Posted : October 4, 2017
Last Update Posted : January 4, 2018
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.
|Condition or disease||Intervention/treatment|
|Lung Transplant||Other: Procedure|
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.
|Study Type :||Observational|
|Estimated Enrollment :||71 participants|
|Official Title:||Prospective Multicenter Cytomegalovirus (CMV) Specific Immune Monitoring to Predict Patient Risk After Lung Transplantation (CTOT-22)|
|Actual Study Start Date :||October 23, 2017|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
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).
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.
- Time from CMV Prophylaxis Discontinuation Post-Transplant to First Detection of CMV Infection or CMV Disease within 6 months Post CMV Prophylaxis Discontinuation [ Time Frame: From CMV Prophylaxis Discontinuation to 6 Months Post CMV Prophylaxis Discontinuation ]Participants will be evaluated for CMV infection or disease according to each center's standard of care clinical protocol. All centers have aligned their clinical practice to include, at a minimum, a CMV infection and a CMV disease assessment at the time of prophylaxis discontinuation, monthly for the first 6 months after discontinuation, and quarterly after that up to 18 months post transplantation.
- Time from CMV Prophylaxis Discontinuation Post-Transplant to First Detection of CMV Infection or CMV Disease Within 18 Months Post-Transplant [ Time Frame: From CMV Prophylaxis Discontinuation to 18-Months Post-Transplant ]Participants will be evaluated for CMV infection or disease according to each center's standard of care clinical protocol. All centers have aligned their clinical practice to include, at a minimum, a CMV infection and a CMV disease assessment at the time of prophylaxis discontinuation, monthly for the first 6 months after discontinuation, and quarterly after that up to 18 months post transplantation.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03300882
|United States, Maryland|
|Johns Hopkins Hospital: Transplantation||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Joby Mathew 410-550-6458 email@example.com|
|Principal Investigator: Pali Shah, MD|
|United States, North Carolina|
|Duke University Medical Center: Transplantation||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Allie Frear 919-684-8914 firstname.lastname@example.org|
|Principal Investigator: John M Reynolds, MD|
|United States, Ohio|
|Cleveland Clinic Foundation: Transplantation||Not yet recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Bette Maierson 216-444-2901 email@example.com|
|Principal Investigator: Marie Budev, DO|
|Toronto General Hospital: Transplantation||Not yet recruiting|
|Toronto, Canada, M5G 2C4|
|Contact: Anam Islam (416) 340-4800 ext 6740 firstname.lastname@example.org|
|Principal Investigator: Lianne Singer, MD|
|Study Chair:||Laurie Snyder, MD, MHS||Duke University Medical Center: Transplantation|
|Study Chair:||Scott Palmer, MD, MHS||Duke University Medical Center: Transplantation|