Performance Comparison of QuantiFERON Monitor in Solid Organ Transplant Recipients

Cell-mediated Immune Response Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02416414
• Other study ID #: CST007_10
• Status: Terminated
• Phase: N/A
• First received: April 7, 2015
• Last updated: March 28, 2016
• Start date: July 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: QIAGEN Gaithersburg, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 166
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cell-mediated Immune Response

Intervention

Device:
• QuantiFERON Monitor Assay
Assay to measure cell-mediated immune function using QuantiFERON Monitor assay.
• Existing methodology
Assay to measure cell-mediated immune function using existing methodology.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of California Los Angeles	Los Angeles	California
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
QIAGEN Gaithersburg, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cell-mediated immune response.		1 day (At time of enrollment)	No