Performance Comparison of QuantiFERON Monitor in Solid Organ Transplant Recipients

NCT ID: NCT02416414

Last Updated: 2016-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

166 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-02-29

Brief Summary

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

Detailed Description

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Conditions

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Cell-mediated Immune Response

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Solid Organ Transplant Recipients

Subjects who have received a Solid Organ Transplant.

QuantiFERON Monitor Assay

Intervention Type DEVICE

Assay to measure cell-mediated immune function using QuantiFERON Monitor assay.

Existing methodology

Intervention Type DEVICE

Assay to measure cell-mediated immune function using existing methodology.

Healthy Controls

Healthy individuals.

QuantiFERON Monitor Assay

Intervention Type DEVICE

Assay to measure cell-mediated immune function using QuantiFERON Monitor assay.

Existing methodology

Intervention Type DEVICE

Assay to measure cell-mediated immune function using existing methodology.

Interventions

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QuantiFERON Monitor Assay

Assay to measure cell-mediated immune function using QuantiFERON Monitor assay.

Intervention Type DEVICE

Existing methodology

Assay to measure cell-mediated immune function using existing methodology.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Provide Informed Consent
* Received a solid organ transplant


* Provide Informed Consent

Exclusion Criteria

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

Healthy Control


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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QIAGEN Gaithersburg, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Camille N Kotton, M.D.

Role: PRINCIPAL_INVESTIGATOR

Transplant and Immunocompromised Host Infectious Diseases

Locations

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University of California Los Angeles

Los Angeles, California, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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CST007_10

Identifier Type: -

Identifier Source: org_study_id

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