NCT03300882

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 4, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

October 31, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2019

Completed
Last Updated

August 6, 2020

Status Verified

August 1, 2020

Enrollment Period

2.1 years

First QC Date

September 25, 2017

Last Update Submit

August 4, 2020

Conditions

Lung Transplant

Keywords

Study co-enrollment (CTOT-20 and CTOT-22)cytomegalovirus (CMV)CMV seropositive positive recipientCMV infectionCMV-specific immunityimmunologic monitoring

Outcome Measures

Primary Outcomes (2)

  • Time from CMV Prophylaxis Discontinuation Post-Transplant to First Detection of CMV Infection or CMV Disease within 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.

    From CMV Prophylaxis Discontinuation to 6 Months Post CMV Prophylaxis Discontinuation

  • Time from CMV Prophylaxis Discontinuation Post-Transplant to First Detection of CMV Infection or CMV Disease Within 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.

    From CMV Prophylaxis Discontinuation to 18-Months Post-Transplant

Study Arms (1)

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).

Other: Procedure

Interventions

ProcedureOTHER

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.

Also known as: Serial blood draws, Phlebotomy, Venipuncture
CMV+ First Lung Transplant Recipients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult lung transplant recipients undergoing lung transplant at one of the four participating centers and concurrently enrolled in CTOT-20 (Clinical Trials.gov ID: NCT02631720).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Johns Hopkins Hospital: Transplantation

Baltimore, Maryland, 21287, United States

Location

Duke University Medical Center: Transplantation

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic Foundation: Transplantation

Cleveland, Ohio, 44195, United States

Location

Toronto General Hospital: Transplantation

Toronto, M5G 2C4, Canada

Location

Related Publications (1)

  • Snyder LD, Chan C, Kwon D, Yi JS, Martissa JA, Copeland CA, Osborne RJ, Sparks SD, Palmer SM, Weinhold KJ. Polyfunctional T-Cell Signatures to Predict Protection from Cytomegalovirus after Lung Transplantation. Am J Respir Crit Care Med. 2016 Jan 1;193(1):78-85. doi: 10.1164/rccm.201504-0733OC.

    PMID: 26372850BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood mononuclear cells (PBMCs) and plasma.

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

MethodsPhlebotomy

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Investigative TechniquesBlood Specimen CollectionSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, Operative

Study Officials

  • Laurie Snyder, MD, MHS

    Duke University Medical Center: Transplantation

    STUDY CHAIR

  • Scott Palmer, MD, MHS

    Duke University Medical Center: Transplantation

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2017

First Posted

October 4, 2017

Study Start

October 31, 2017

Primary Completion

November 25, 2019

Study Completion

November 25, 2019

Last Updated

August 6, 2020

Record last verified: 2020-08

Locations

CA(1)US(3)