A Study to Evaluate Immunodiagnosis of Tuberculosis Infection with Flow Cytometry

Overview

Información sobre este estudio

The purpose of this study is to compare the diagnostic accuracy and potential predictive value of tuberculin skin test (TST) and interferon-g release assays (IGRAs) with FCA, multiplexed cytokine and chemokine profiling (MCCP), RNA transcriptional signatures (RTS) testing for latent tuberculosis infection (LTBI) in patients with and without immunosuppression.

 

 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Patients and subjects 18 years or older and in stable medical condition.
  • Patients at low risk for TB infection:
    • Being born in a low-incidence TB area, and low risk for contact with TB cases (i.e., no prior work or history of staying in a potentially TB transmissible area such as inpatient hospital facility, jail or prison, or nursing home); or
    • Who also are tested for job screening purposes or prior to initiation of immunosuppressive therapy.
  • Patients at intermediate to high risk for TB infection: Recent TST or IGRA testing, or clinical indication for either TST or IGRA testing (i.e., Contacts of TB cases, foreign-born subjects without other risk factors for TB infection, patients on immunosuppressive therapy, chronic medical conditions at risk of TB infections, healthcare worker screening, etc.). We will also include patients with history of prior discordant TST and QuantiFERON TB Gold/In-Tube™ results.
  • Patient with recent diagnosis of culture-proven TB infection or on treatment for active TB, pending final culture results.
  • Signed written informed and HIPAA consent.

Exclusion Criteria:

  • Patients younger than 18 years old.
  • Patients unable to perform the study protocol.
  • Patients unwilling or unable to give written informed consent.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Patricio Escalante, M.D., M.S.

Abierto para la inscripción

Contact information:

Kale Daniel

(507) 266-4541

Daniel.Kale@mayo.edu

More information

Publicaciones

Publications are currently not available
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CLS-20492439

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