Ommaya Placement for Biomarker Collection

Overview

Información sobre este estudio

The purpose of this study is to determine the safety and feasibility of intra-operative Ommaya Reservoir placement during a clinically indicated tumor surgery in order to facilitate a longitudinal access to cerebrospinal fluid (CSF) for analysis of exploratory and future tumor biomarkers for individualized monitoring.

 

 

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:

  • Age ≥18 years.
  • Clinical and radiographic evidence suggesting a diagnosis of a brain tumor.
  • Planned neurosurgical procedure resection of suspected or previously diagnosed brain tumor as part of routine clinical care.
  • Willing to undergo neurosurgical resection at Mayo Clinic (Rochester, MN).
  • Ability to understand and the willingness to sign a written informed consent document.
  • Patient is willing to have their Ommaya sampled on at least 2 future occasions.
  • Patients is willing to have cerebrospinal fluid (CSF) banked through the neuro-oncology biorepository (requires a separate signature).

 Exclusion Criteria:

  • Vulnerable populations: pregnant women, prisoners, or the mentally handicapped.
  • Patients who are not appropriate candidates for surgery due to current or past medical history or uncontrolled concurrent illness.
  • Prior history of any wound infection.
  • Any patient who the surgeon feels is not an optimal candidate for Ommaya reservoir placement. Such reasons may (but need not necessarily) include surgical anatomy clinical evidence of significant immunosuppression, and/or elevated risk of wound infection due to diabetes, smoking history, morbid obesity, or any other concerns. 

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

Terence Burns, M.D., Ph.D.

Abierto para la inscripción

Contact information:

Amanda Munoz Casabella M.D.

MunozCasabella.Amanda@mayo.edu

More information

Publicaciones

Publications are currently not available
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CLS-20508001

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