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A Study to Compare Intravesical Therapy and Surgery to Treat Bladder Cancer

Overview

Información sobre este estudio

The purpose of CISTO is to conduct a large prospective study that directly compares the impact of medical management versus bladder removal in recurrent high-grade NMIBC patients with BCG (Bacillus Calmette-Guerin) failure on clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).

Bladder cancer is the most common urinary tract cancer and the 5th most common cancer in the US. Yet bladder cancer research is underfunded relative to other common cancers. As a result, bladder cancer care is prone to evidence gaps that produce decision uncertainty for both patients and clinicians. The Comparison of Intravesical Therapy and Surgery as Treatment Options (CISTO) for Bladder Cancer Study has the potential to fill these critical evidence gaps, change care pathways for the management of NMIBC (non-muscle-invasive bladder cancer), and provide for personalized, patient-centered care.

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:

  • Adult 18 years of age or older.
  • Presenting with high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1, and with:
    • Pathology documentation from any hospital/clinic/medical center;
    • More than 50% urothelial carcinoma component in the specimen;
    • History of high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1;
    • Attempted or received induction BCG (at least 3 out of 6 instillations) at any point in time;
    • Received at least one instillation of any intravesical agent within previous 12 months.

Exclusion Criteria:

  • Any plasmacytoid or small cell (neuroendocrine) component in the pathology (past or current presentation).
  • Previous history of cystectomy or radiation therapy for bladder cancer.
  • Previous history of muscle-invasive bladder cancer or metastatic bladder cancer.
  • Any history of upper tract urothelial carcinoma.
  • Incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening.
  • Contraindication to radical cystectomy (e.g., ASA of 4).
  • Contraindication to medical therapy (i.e., intolerant of all medical therapies).
  • Unable to provide written informed consent in English.
  • Unable to be contacted for research surveys.
  • Planning to participate in a Phase I/II interventional clinical trial for NMIBC or any blinded interventional trial for NMIBC.

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

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Mark Tyson, M.D., M.P.H.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20516955

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