Innovative Therapeutic Treatments to Inhibit Perineural Invasion in Pancreatic Adenocarcinoma

NCT06616688 | Not Yet Recruiting

• 1 other identifier: PNRR-MCNT1-2023-12378106
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The overall goal of this project is to develop new therapeutic approaches to limit Perineural invasion (PNI) in pancreatic ductal adenocarcinoma (PDAC). PNI, has its higher incidence in PDAC, in which it is a recognized risk factor of poor survival. Considering the clinical relevance of PNI and its role in PDAC, it is urgent to identify molecular PNI signatures to develop new therapeutic strategies. We have recently identified a molecule that is activated in pancreatic cancer cells and initiate PNI. In this project we will hamper the signaling of this molecule in vitro, in human and murine organoids cocultured with myelinated Schwann cells neuronal cocultures, and in vivo in a mouse model faithfully reproducing human PNI. Thus, we will enroll patients undergoing surgical resection for PDAC, and a small piece of the resected tissue, performed for normal clinical practice after pathology evaluation, will be used to develop organoids. This project is designed as an observational multicentric, transversal study. San Raffaele Hospital (OSR) is the only center enrolling patients. The main goal of this Aim is to validate the effectiveness of NP-loaded hydrogel-based developed by CNR Nanotec Lecce, in vitro in organoids, which represent a suitable system to study PDAC.

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Outcome Measures

Primary Outcomes (1)

• Prepare and validate nanoparticles releasing FGFBP1 inhibitors

  Readout of these analyses will be the safety of developed hydrogels and effective release of FGFBP1 inhibitors.

  8 months to assess hydrogels' safety and release of FGFBP1 inhibitors in NP-loaded hydrogels 12 months to complete the task

Secondary Outcomes (1)

• Treat peripheral myelinated cocultures with nanoparticles-loaded hydrogels targeting FGFBP1 signaling

  Extent of myelin degeneration 3, 7-, 10-, 15- and 21-days post seeding human and mouse derived organoids mous

Interventions

Organoid-guided treatment OTHER

After specimen removal as per clinical practice and pathological examination, a small piece of tumor tissue will be sent to the Axo-Glial Interaction Unit and cultured to build up organoid cultures

Also known as: Organoids colture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing surgical pancreatic resection, as per clinical practice, with clinically and radiologically confirmed diagnosis of ductal adenocarcinoma. All patients will be enrolled at the OSR Pancreatic and Transplant Surgery Unit.

You may qualify if:

• Age \>18 years (also fertile patients ca be included)
• Surgical resection for suspected PDAC, as per clinical practice. We will use this material both for controls and for the case samples.

You may not qualify if:

• Patients \< 18 years of age
• Patients who are not able to sign an informed consent
• Patients with suspected PDAC non confirmed at pathological report

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• National Nanotechnology Center (NANOTEC), The National Science and Technology Development Agency (NSTDA): collaborator

Central Study Contacts

Massimo Falconi

CONTACT

+390226436046; pancreatic.surgery@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pancreatic Surgery

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: September 27, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR