Performance Comparison of QuantiFERON Monitor in Solid Organ Transplant Recipients

March 28, 2016 updated by: QIAGEN Gaithersburg, Inc
To compare the performance of the QuantiFERON Monitor assay against existing methodology.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

166

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90024
        • University of California Los Angeles
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who have either received a solid organ transplant or who are healthy.

Description

Solid Organ Transplant Recipient

Inclusion Criteria:

  • Provide Informed Consent
  • Received a solid organ transplant

Exclusion Criteria:

  • Pregnancy or recent lactation (<1yr)
  • Treatment of Rejection

Healthy Control

Inclusion Criteria:

  • Provide Informed Consent

Exclusion Criteria:

  • Currently taking any immunomodulatory medication
  • A history of immunosuppressive disease or immunosuppression condition or history of autoimmune diseases
  • Current pregnancy or recent lactation (<1yr)
  • Currently taking antiviral medication
  • Currently being treated for infectious diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Solid Organ Transplant Recipients
Subjects who have received a Solid Organ Transplant.
Device: QuantiFERON Monitor Assay
Assay to measure cell-mediated immune function using QuantiFERON Monitor assay.
Device: Existing methodology
Assay to measure cell-mediated immune function using existing methodology.
Healthy Controls
Healthy individuals.
Device: QuantiFERON Monitor Assay
Assay to measure cell-mediated immune function using QuantiFERON Monitor assay.
Device: Existing methodology
Assay to measure cell-mediated immune function using existing methodology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cell-mediated immune response.
Time Frame: 1 day (At time of enrollment)
1 day (At time of enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

QIAGEN Gaithersburg, Inc

Investigators

  • Principal Investigator: Camille N Kotton, M.D., Transplant and Immunocompromised Host Infectious Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

April 7, 2015

First Submitted That Met QC Criteria

April 9, 2015

First Posted (Estimate)

April 15, 2015

Study Record Updates

Last Update Posted (Estimate)

March 29, 2016

Last Update Submitted That Met QC Criteria

March 28, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • CST007_10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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