NCT02560857

Brief Summary

The study will prospectively determine the clinical utility of non-pathogen specific cellular immunity assessment using the Quantiferon-Monitor to quantify the degree of immunosuppression. The investigators will use the results of the assay to predict whether patients develop opportunistic infections and predict organ rejection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

June 20, 2018

Status Verified

June 1, 2018

Enrollment Period

2 years

First QC Date

September 23, 2015

Last Update Submit

June 18, 2018

Conditions

Immunity, Cellular

Keywords

Quantiferon-Monitororgan rejectionglobal immunity

Outcome Measures

Primary Outcomes (1)

  • Number of participants that develop Opportunistic infections

    The results of the assay will be used to predict whether patients develop opportunistic infections.

    1 year

Secondary Outcomes (1)

  • Number of participants that develop Acute cellular rejection

    1 year

Interventions

Quantiferon-Monitor assayOTHER

The QFT-Monitor assay is a recently developed non-pathogen specific immune assay based on immune activation of both innate and adaptive immunity.

Eligibility Criteria

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

Adult SOT recipients on at least one immunosuppressive medication.

You may qualify if:

  • Adult SOT recipients on at least one immunosuppressive medication able to comply with the protocol.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network, Toronto General Hospital, Multi-Organ Transplant

Toronto, Ontario, M5G2N2, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood samples (plasma will be extracted to perform Quantiferon-Monitor test)

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physician, Transplant Infectious Diseases

Study Record Dates

First Submitted

September 23, 2015

First Posted

September 25, 2015

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

May 1, 2018

Last Updated

June 20, 2018

Record last verified: 2018-06

Locations

CA(1)