Immunogenic Cell Death as a Novel Mechanism of Mitomycin C Activity in Bladder Cancer (ICH-MIM-01)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Urothelial or transitional cell carcinoma of the bladder is the fourth most common cancer in males worldwide, with about 60-80% of newly diagnosed patients having non-muscle-invasive bladder cancer (NMIBC). NMIBC management consist in transurethral resection of bladder tumor (TURBT) followed by adjuvant intravesical treatment with the chemotherapeutic agent Mitomycin C (MMC) or the immunotherapy bacillus Calmette-Guérin. These therapies result in low progression rates, but are not efficacious in all patients, leading to high tumor recurrence. Immunogenic cell death (ICD) may be one of the mechanisms of action of MMC intravesical therapy in bladder cancer.
The primary objective of the study is to evaluate whether MMC is able to trigger ICD in patient-derived neoplastic tissues. As secondary targets we aim to:
- identify an expression profile that is common to all tumors that undergo ICD upon MMC treatment ('ICD signature'),
- asses the genetic and environmental factors- urinary microbiome composition- responsible for MMC treatment efficacy,
- evaluate whether ICD induction correlates with clinical staging and response (clinical endpoints for MMC-treated patients are recurrence at three month and one year after enrollment).
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Milan
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Rozzano, Milan, Italia, 20089
- Reclutamiento
- Humanitas reseach hospital (ICH)
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
80 patients with carcinoma of the bladder; divided in 20 patients Ta (low grade), 20 patients Ta/T1 (high grade) and 20 patients T2. Only for liquid samples collection we will include 20 CIS (carcinoma in situ) patients.
30 age and sex-matched subjects not suffering from carcinoma of the bladder, already hospitalized in ICH; we expect to enroll 24 males and 6 females of which 10 of 40- 60 years old, 10 of 60-70 years old, 10 of >70 years old.
Descripción
Inclusion Criteria:
- Male and females, > 40 years old
For bladder cancer patients:
- bladder cancer patients- patinets with first tumor occurrence or patient with a recurrence after more than 2 years from the removal of the prior malignancy
Exclusion Criteria:
- Treated with immunomodulatory agents at time of enrollment or in the two months before enrollment
- Treated with antibiotics at time of enrollment or during the month before enrollment
- Positive history of sexually transmitted diseases
- Urinary infection ongoing or recent (during the three months before enrollment)
- Suffering from chronic intestinal inflammation
ONLY for controls:
- Treated with immunomodulatory agents at time of enrollment or in the two months before enrollment
- Treated with antibiotics at time of enrollment or during the month before enrollment
- Positive history of sexually transmitted diseases
- Urinary infection ongoing or recent (during the three months before enrollment)
- Suffering from chronic intestinal inflammation
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Bladder cancer patients
80 patients with carcinoma of the bladder; divided in 20 patients Ta (low grade), 20 patients Ta/T1 (high grade) and 20 patients T2.
Only for liquid samples collection we will include 20 CIS (carcinoma in situ) patients
|
urine collection: DNA is isolated from urine samples (catheterized, washout, midstream) and the 16S rRNA gene is sequenced. Specimen collection: Specimens collected during TURBT are selected by a pathologist and trasferred to the laboratory. The tissues are treated ex vivo with MMC. |
|
Controls- Healthy subjects
30 age and sex-matched subjects not suffering from carcinoma of the bladder, already hospitalized in ICH; we expect to enroll 24 males and 6 females of which 10 of 40- 60 years old, 10 of 60-70 years old, 10 of >70 years old.
|
urine collection: DNA is isolated from urine samples (catheterized, washout, midstream) and the 16S rRNA gene is sequenced. Specimen collection: Specimens collected during TURBT are selected by a pathologist and trasferred to the laboratory. The tissues are treated ex vivo with MMC. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
MMC-induced ICD
Periodo de tiempo: 3 years
|
The main aim of this study is to evaluate whether MMC is able to trigger ICD in patient-derived neoplastic tissues.
|
3 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
ICD signature analyzed by RNAseq analysis
Periodo de tiempo: 3 years
|
Identify an expression profile that is common to all tumors that undergo ICD upon MMC treatment ('ICD signature')
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3 years
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Microbiota study
Periodo de tiempo: 3 years
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Verify the existance of urinary microbiome using catheterized urines and identify changes in urinary microbiome composition correlating with bldder cancer, MMC efficacy and staging/progression of the disease
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3 years
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2041
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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