NCT07500259

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 188 (estimated)
• Sponsor: Luxembourg Institute of Health · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The ColoPan study evaluates the scientific validity, reproducibility, and predictive performance of the Personalised Functional Profiling (PFP) platform in colorectal cancer and pancreatic ductal adenocarcinoma patients. It combines genomic sequencing with in vitro functional drug testing using patient-derived spheroids/organoids.

Detailed description

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.

Conditions

• Colorectal Cancer
• PDAC - Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
OTHER	Personalized Functional Profiling	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)

Timeline

• Start date: 2026-05-01
• Primary completion: 2029-09-30
• Completion: 2034-11-01
• First posted: 2026-03-30
• Last updated: 2026-03-30