The ACC Preclinical Research Platform for Precision Oncology

Solid Tumor Clinical Trial

— ACC Platform  

Official title:

La Piattaforma ACC di Ricerca Preclinica Per l'Oncologia di Precisione

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06339541
• Other study ID #: 029-FPO23
• Status: Recruiting
• Start date: June 5, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: Fondazione del Piemonte per l'Oncologia
• Contact: Enzo Medico, MD
• Phone: +390119933234
• Email: enzo.medico[@]ircc.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The ACC Preclinical Research Platform for Precision Oncology is a retrospective and prospective observational study focused on the implementation and validation of the application of PDCM (Patient Derived Cancer Models) generated from tissues or cells of patients with neoplastic disease, as a tool to improve molecular and biological knowledge of tumours and to test the efficacy and sensitivity of pharmacological treatments.

Description:

This is a retrospective and prospective observational study, focused on the implementation and validation of the application of PDCM, generated from tissue or cells of patients, including paediatric patients, with solid and haematological malignancies, as a tool to improve molecular and biological knowledge of tumours and to test the efficacy and sensitivity of pharmacological treatments.

An up-to-date database of all PDCMs available at the participating italian hospitals will be generated and enriched with new models generated during the course of the project. The sharing of models and procedures between the different hospitals will facilitate their molecular and phenotypic characterisation, also in parallel with the tumours of origin, as well as their validation as tools for testing the efficacy of drugs for precision medicine. By establishing common workflows and standards and performing cross-validation experiments it is planned to build a network of reference centres as a resource for drug screening on 2D and 3D models.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• Patients, including paediatric patients, with solid and haematological malignancies for whom tissue or tumour cell material is available.

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Solid Tumor

Locations

Country	Name	City	State
Italy	Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo	Candiolo	Turin

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione del Piemonte per l'Oncologia	Alleanza Contro il Cancro

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of PDCM (patient derived cancer models)	PDCM will be generated from tissues and cells	12 months
Primary	number of Whole Exome Sequencing (WES) e RNA-seq performed	WES and RNA seq will be performed on tissues and blood	12 months
Secondary	number of PDCM shared within the network	PDCM will be generated from tissues and cells and shared within the network	12 months