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

NCT07500259 | Not Yet Recruiting

• 1 other identifier: COLOPAN
• Study Type: observational
• Target: 188
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Colorectal Cancer; PDAC - Pancreatic Ductal Adenocarcinoma

Keywords

Drug profiling; Precision medicine; clinical validation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Assessment of the exploratory value of PFP-derived functional profiles

  0-5 years

• Feasibility and Operational Evaluation of the PFP Platform

  0-5 years

Study Arms (2)

CRC

Participants are included while scheduled for biopsy or surgery of their colorectal cancer.

Other: Personalized Functional Profiling

PDAC

Participants are included while scheduled for biopsy or surgery of their cancer.

Other: Personalized Functional Profiling

Interventions

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)

CRC; PDAC

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

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Luxembourg Institute of Health: lead
• Hopitaux Robert Schuman: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tissues are collected at incluision and in case of additional surgeries

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Yong Jun Kwon, phD

CONTACT

+352 26970-288; yong-jun.kwon@lih.lu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): November 1, 2034
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be made available for collaboration after publication