Exploratory Clinical Evaluation of Personalized Functional Profiling in GI Tumors: Predicting Drug Response in CRC and PDAC

The ColoPan study aims to evaluate the scientific validity, reproducibility, and predictive performance of the Personalised Functional Profiling (PFP) platform in colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) patients. The approach combines genomic sequencing with in vitro functional drug testing using patient-derived spheroids/organoids (PDSOs). The study aims to generate robust evidence that could inform the design of future interventional trials and contribute to the broader goal of refining personalised oncology strategies. The current protocol focuses on the new enrolment of PDAC participants, while data generated from prospective enrolment or biospecimens collected under the ethically approved SOCS study will be used under a secondary use agreement. The study aims to assess the scientific validity and predictive performance of the PFP platform in precision oncology research for CRC and PDAC, determining whether drug sensitivity profiles correlate with actual patient outcomes. The study also explores the feasibility of implementing PFP workflows in research settings and their potential for future integration into clinical trial design.

• Personalized Functional Profiling (Other): This is an observational study where biological samples are collected to provide Personalized Functional Profiling, an integrated strategy that combines genomic analysis with direct drug response assessments using patient-derived spheroids/organoids (PDSOs)

Primary outcomes

• PFP platform's predictive performance [0-5 years]: Degree of concordance between drug sensitivity profiles generated by the PFP platform and actual clinical responses observed in patients with CRC and PDAC treated with Standard of Care therapies.

Secondary outcomes

• Assessment of the exploratory value of PFP-derived functional profiles [0-5 years]: Correlation between the ex vivo drug sensitivity data and observed clinical outcomes
• Feasibility and Operational Evaluation of the PFP Platform [0-5 years]: Take-on rate of patient samples-defined as the percentage of collected samples that successfully led to PDSO generation and subsequent drug screening.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Signed informed consent form
* ≥ 18 years of age
* Willing and able to comply with the protocol for the duration of the study, including data and sample collection
* Patient scheduled for surgery or biopsy (primary tumour or metastasis) PDAC

Exclusion Criteria:

* Female patient, pregnant, planning a pregnancy or breastfeeding.
* Known active Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection.
* Patient unable to understand and provide informed consent and has no family member representing him/her.
* Patients with any other life-threatening illness, significant organ dysfunction or any clinically relevant conditions that, according to the hospital physician, could compromise the patient's safety.