Viewing Study NCT06315868



Ignite Creation Date: 2024-05-06 @ 8:15 PM
Last Modification Date: 2024-10-26 @ 3:24 PM
Study NCT ID: NCT06315868
Status: RECRUITING
Last Update Posted: 2024-03-18
First Post: 2023-05-11

Brief Title: Breast Cancer Subtype Characterization Through Patients Derived Organoids
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Overview

Official Title: Breast Cancer Subtype Characterization Through Patients Derived Organoids BCinsightPDO
Status: RECRUITING
Status Verified Date: 2023-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: BCinsightPDO
Brief Summary: Development of tools to predict patients chemo-sensitivity and identification of corresponding biomarkers is an urgent challenge for BC patients lacking targeted therapies such as TNBC or for patients experiencing relapse after adjuvant chemotherapy or targeted therapies

The refinement of 3D-cultivation techniques experienced in the last decade has allowed cultivation of patients-derived cancer cells in organotypic structures named patient-derived organoids PDO which preserve histologic genomic and transcriptomic features of primary tumors PDO allow propagation pharmacological treatment and genetic manipulation of patients-derived cancer cells in a close to physiology setting thus representing a promising tool in the development of personalized therapies
Detailed Description: PDO have been shown to efficiently recapitulate ex-vivo the in vivo response to hormonal treatment of BC patients These observations point to PDO as potential valuable tools for a rapid personalized prospective evaluation of patient-specific chemo-sensitivity Moreover PDO can represent a valuable ex-vivo platform for screening new treatments or combination of current treatments in a medium-to-high-throughput fashion Thus development of a stable collection of PDO representing the heterogeneity of BC subtypes including the evolution of recurrent disease represents an extremely useful resource for both prospective and retrospective studies aimed at understanding the molecular phenotype associated with chemoresistance

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None