Defining the Immunologic Profile of Sentinel Lymph Nodes and Identifying the Mechanisms Responsible for Immunosuppression

Overview

Información sobre este estudio

The purpose of this study is to look at the effects cancer and melanoma have on the immune cells found in lymph nodes.

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:

The patients on this protocol will have been evaluated and treated for their cancer using the standard of care as discussed by the treating physician.

Cohort 1: 

  • Histologically confirmed primary cutaneous melanoma
  • Patients with clinically stage I-II melanoma
  • 18 years of age and older
  • Breslow depth of invasion > 0.75 mm
  • Patients who are undergoing a sentinel lymph node (SLN) biopsy as part of their surgical intervention as determined by their treating surgeon.
  • Patients on the following immunosuppressive medications can be considered for accrual (but use of these medications will be documented by the study coordinator if used within 6 weeks of surgery)
    • Aspirin (daily)
    • Ibuprofen
    • NSAIDs
    • Low dose steroids
  • Consent to pre-operative 10cc peripheral blood draw

Cohort 2:

  • Women 18 years of age or older
  • Patients who have chosen to undergo a prophylactic mastectomy.
  • Patients on the following immunosuppressive medications can be considered for accrual (but use of these medications will be documented by the study coordinator if used within 6 weeks of surgery)
    • Aspirin (daily)
    • Ibuprofen
    • NSAIDs
    • Low dose steroids

Exclusion Criteria:

Cohort 1:

  • Biopsy proven regional lymph node involvement.
  • Immunosuppressive medications within the past 6 weeks including:
    • High dose steroids
    • TNF-inhibitors
    • Methotrexate
    • IL-1Ra antagonist
  • Women who are pregnant or nursing
  • Elect not to provide peripheral blood draw

Cohort 2:

  • History of ipsilateral breast cancer
  • Contralateral inflammatory breast cancer
  • Incidental invasive breast cancer identified in the ipsilateral breast during pathologic review of the mastectomy specimen.
  • No lymph node identified in the ipsilateral breast during pathologic review of the mastectomy specimen
  • Neoadjuvant chemotherapy within the past year
  • Immunosuppressive mediations within the past 6 weeks including:
    • High dose steroids
    • TNF-inhibitors
    • Methotrexate
    • IL-1Ra antagonist
  • Women who are pregnant or nursing

 

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

Svetomir Markovic, M.D., Ph.D.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Investigador principal de Mayo Clinic

James Jakub, M.D.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

Publications are currently not available

Información adicional de contacto

Formulario de contacto para ensayos sobre cáncer

Teléfono: 855-776-0015 (toll-free)

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