Exploratory Clinical Evaluation of Personalized Functional Profiling in GI Tumors: Predicting Drug Response in CRC and PDAC (COLOPan)
June 18, 2026 updated by: Luxembourg Institute of Health
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yong Jun Kwon, phD
- Phone Number: +352 26970-288
- Email: yong-jun.kwon@lih.lu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
CRC
Participants are included while scheduled for biopsy or surgery of their colorectal cancer.
|
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.
|
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
Time Frame: 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.
|
0-5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of the exploratory value of PFP-derived functional profiles
Time Frame: 0-5 years
|
Correlation between the ex vivo drug sensitivity data and observed clinical outcomes
|
0-5 years
|
|
Feasibility and Operational Evaluation of the PFP Platform
Time Frame: 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.
|
0-5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 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)
June 23, 2026
Last Update Submitted That Met QC Criteria
June 18, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.