Development and Validation of a Prognostic Transcriptomic Signature for Chronic Hypersensitivity Pneumonitis: PREDICT-HP

Overview

Información sobre este estudio

The purpose of this study is to establish and validate testing for disease progression in peripheral mononuclear cells (PMBC) from patients with Chronic Hypersensitivity Pneumonitis (CHP) at initial presentation, and to validate blood tests over time to predict disease progression.

 

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:

  • Diagnosis of Chronic Hypersensitivity Pneumonitis (CHP) defined from the first instance in which a patient was informed of having CHP for at least 3 months.
  • Age 18 through 85 years.
  • Diagnosis of CHP by HRCT:
    • Typical CHP: Evidence of lung fibrosis (reticular abnormality and/or, traction bronchiectasis and/or, architectural distortion, and/or honeycombing), lack of features suggesting an alternative diagnosis and one or more of the following:
      • Profuse poorly defined centrilobular nodules of ground-glass opacity affecting all lung zones;
      • Inspiratory mosaic attenuation with three-density sign.
    • Compatible CHP*: Evidence of lung fibrosis (as above) lack of features suggesting an alternative diagnosis and one or more of the following:
      • Patchy or diffuse ground-glass opacity;
      • Patchy, non-profuse centrilobular nodules of ground-glass attenuation;
      • Mosaic attenuation and lobular air-trapping that do not meet criteria for typical fibrotic HP.

* These patients are required to have a known or indeterminate (suggestive) antigen exposure and/or BAL lymphocytosis (≥ 20%) and/or lung histology consistent with HP (e.g., transbronchial biopsies demonstrating non-necrotizing granuloma(s) or lymphocytosis and/or wedge biopsy or cryobiopsy with a typical, compatible or indeterminate pattern for HP).

  •  
  • Indeterminate CHP**:  CT signs of fibrosis without other features suggestive of HP.

** These patients are required to have a known or indeterminate (suggestive) antigen exposure and/or BAL lymphocytosis (≥ 20%) and/or lung histology consistent with HP (e.g., transbronchial biopsies demonstrating non-necrotizing granuloma(s) or lymphocytosis and/or wedge biopsy or cryobiopsy with a typical, compatible or indeterminate pattern for HP).

  • Able to understand and sign a written informed consent form.
  • Able to understand the importance of adherence to the study protocol and willing to follow all study requirements (e.g., completing procedures such as 6-min walk and questionnaires).

Exclusion Criteria:

  • Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study (e.g., unstable or deteriorating cardiac disease such as congestive heart failure requiring hospitalization or unstable angina).
  • Known explanation for the interstitial lung disease, including but not limited to radiation, drug toxicity, sarcoidosis, pneumoconiosis.
  • Clinical diagnosis of any connective tissue disease, including but not limited to scleroderma, polymyositis/dermatomyositis, and rheumatoid arthritis.
  • Expected to receive a lung transplant within 4 months from enrollment.
  • Pregnant women.

Eligibility last updated 9/27/21. Questions regarding updates should be directed to the study team contact.

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

Teng Moua, M.D.

Cerrado; inscripción por invitación

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El estudio no está abierto para todos los que cumplen con los criterios de elegibilidad, sino solamente para las personas que el equipo del estudio ha invitado a participar.

Contact information:

Shannon Daley C.C.R.C., CCRP

(507) 293-0637

Daley.Shannon@mayo.edu

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