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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; PDAC - Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Other: Personalized Functional Profiling

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.

• Study Type: Observational
• Enrollment (Estimated): 188

Contacts and Locations

• Study Contact: Name: Yong Jun Kwon, phD; Phone Number: +352 26970-288; Email: yong-jun.kwon@lih.lu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study targets patients undergoing surgery or biopsy at Hôpital Robert Schuman (HRS) in Luxembourg.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CRC; Participants are included while scheduled for biopsy or surgery of their colorectal cancer.	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)
PDAC; Participants are included while scheduled for biopsy or surgery of their cancer.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFP platform's predictive performance	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.	0-5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Luxembourg Institute of Health
• Collaborators: Hopitaux Robert Schuman

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): November 1, 2034

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Precision medicine; clinical validation; Drug profiling
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: COLOPAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The participant will be proposed to signed a secondary use notice. For the participants who agreed, samples and data will be open for sharing to other researchers in collaboration.
• IPD Sharing Time Frame: Data will be made available for collaboration after publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No