Performance Comparison of QuantiFERON Monitor in Solid Organ Transplant Recipients

Terminated

• Conditions: Cell-mediated Immune Response
• Interventions: Device: QuantiFERON Monitor Assay; Device: Existing methodology

• Registration Number: NCT02416414
• Lead Sponsor: QIAGEN Gaithersburg, Inc

Brief Summary

To compare the performance of the QuantiFERON Monitor assay against existing methodology.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-07
• Study First Submitted QC: 2015-04-09
• Study First Posted: 2015-04-15
• Study Start: 2015-07
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-28
• Last Update Posted: 2016-03-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 166

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Solid Organ Transplant Recipients	Existing methodology	Subjects who have received a Solid Organ Transplant.
Healthy Controls	QuantiFERON Monitor Assay	Healthy individuals.
Solid Organ Transplant Recipients	QuantiFERON Monitor Assay	Subjects who have received a Solid Organ Transplant.
Healthy Controls	Existing methodology	Healthy individuals.

Primary Outcome Measures

Name	Time	Method
Cell-mediated immune response.	1 day (At time of enrollment)

Trial Locations

Locations (4)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

The Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States