Defining Inflammation Related to Peritoneal Carcinomatosis in Women With Ovarian or Colon Cancer.

Molecular Characterisation and Clinical Implications of Inflammation Related to Peritoneal Carcinomatosis in Women With Ovarian or Colon Cancer.

Patrocinadores

Patrocinador principal: University of Pisa

Fuente University of Pisa
Resumen breve

Inflammation plays an important role in the pathogenesis of peritoneal carcinosis. Patients with elevated levels of different inflammation cytokines show a worse prognosis at the time of diagnosis. In women, ovarian and colon cancer are the main causes of peritoneal carcinosis and a comparison of these two different types of peritoneal invasion have not been conducted yet. We found interesting studying the role of immune response, in particular tumour-associated antigens (TAA) that modulate the metastatic process. We will investigate also mitochondrial defects, such as mutations in mt-DNA, potentially involved in carcinogenesis.

Descripción detallada

At the time of hospitalization all the patients will undergo a complete clinical evaluation with determination of biochemical parameters such as fasting blood glucose, blood count, hs-CRP, AST and ALT, uric acid, creatinine and BUN. An extra blood aliquot will be collected to assess the serum biomarkers under investigation.

During surgery two samples of peritoneal tissue macroscopically undamaged will be collected. On those samples will be executed separation of adipocytes cells, RNA and protein extraction for measuring of inflammatory and neoplastic biomarkers, determination of P2X7R-inflammasome activity and mitochondrial DNA analyse.

Estado general Completed
Fecha de inicio March 1, 2017
Fecha de Terminación March 30, 2019
Fecha de finalización primaria June 1, 2018
Tipo de estudio Observational [Patient Registry]
Resultado primario
Medida Periodo de tiempo
Immune biomarkers level Each patients will be assessed at baseline
Metastatic mediators level Each patients will be assessed at baseline
P2X7R-inflammasome activity Each patients will be assessed at baseline
Inscripción 30
Condición
Intervención

Tipo de intervención: Procedure

Nombre de intervención: Cytoreductive surgery

Descripción: Partial removal of peritoneal tissue involved by neoplastic invasion

Otro nombre: Debulking

Elegibilidad

Método de muestreo: Non-Probability Sample

Criterios:

Inclusion Criteria:

- histological diagnosis of peritoneal carcinosis secondary to colon cancer or high-grade ovarian cancer

- patients able to consent

Exclusion Criteria:

- previous malignancies, except for patients with cutaneous basal cell carcinoma, Cervical Intraepithelial Neoplasia (CIN) or melanoma in situ

- current chemotherapy or radiotherapy

- current steroid therapy or immunotherapy

- patients affected by systemic inflammatory disease and/or Inflammatory bowel disease (IBD)

Género: Female

Basado en el género: Yes

Edad mínima: 25 Years

Edad máxima: 75 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Anna Solini, MD, PhD Principal Investigator University of Pisa
Ubicación
Instalaciones: University of Pisa
Ubicacion Paises

Italy

Fecha de verificación

November 2019

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: University of Pisa

Nombre completo del investigador: Anna Solini

Título del investigador: Associate Professor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Grupo de brazo

Etiqueta: Ovarian cancer

Descripción: Patients affected by ovarian cancer will be stratified according to BRCA1 and BRCA2 mutational status.

Etiqueta: Colon cancer

Descripción: Patients affected by colon cancer will be similarly stratified according to BRAF and KRAS mutational status and to the presence of low-grade or high-grade microsatellite instability (MSI).

Acrónimo CarFlog
Información de diseño del estudio

Modelo de observación: Cohort

Perspectiva de tiempo: Prospective

Fuente: ClinicalTrials.gov