Colorectal CancerCOLOPanNCT07500259
Exploratory Clinical Evaluation of Personalized Functional Profiling in GI Tumors: Predicting Drug Response in CRC and PDAC
An observational study of Colorectal Cancer and PDAC - Pancreatic Ductal Adenocarcinoma, run by Luxembourg Institute of Health at 1 site in Luxembourg.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, PDAC - Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Personalized Functional Profiling
- How many people
- 188 participants
- Where
- 1 siteLuxembourg
- Study dates
- 11 Sep 2026to 1 Nov 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study targets patients undergoing surgery or biopsy at Hôpital Robert Schuman (HRS) in Luxembourg.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Luxembourg1 site, 1 recruiting
- Recruiting
Hôpitaux Robert Schmuan
Luxembourg, Luxembourg, 2540
Marc Berna, MD, +352 (28) 88 6550, marc.berna@hopitauxschuman.lu
About this study
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.
Read the 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.
- Being tested
- Personalized Functional Profiling
- Keywords
- Drug profiling, Precision medicine, clinical validation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Functional ProfilingOther
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)
| Study group | Role | What they receive |
|---|---|---|
| CRC | Participants are included while scheduled for biopsy or surgery of their colorectal cancer. Receives: Other: Personalized Functional Profiling | |
| PDAC | Participants are included while scheduled for biopsy or surgery of their cancer. Receives: Other: Personalized Functional Profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-5 years
Secondary outcomes (2)
Assessment of the exploratory value of PFP-derived functional profiles
Correlation between the ex vivo drug sensitivity data and observed clinical outcomes
Measured: 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.
Measured: 0-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start11 Sep 2026
- Primary completion30 Sep 2029 (estimated)
- Study completion1 Nov 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luxembourg Institute of Health
- Sponsor type
- Other government
- Collaborators
- Hopitaux Robert Schuman
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500259
- Sponsor's protocol ID
- COLOPAN
- Acronym
- COLOPan
- Status last verified
- Sep 2026
- First submitted
- 24 Mar 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Evaluation of Personalized Functional Profiling in GI Tumors: Predicting Drug Response in CRC and PDAC
- ClinicalTrials.gov ID
- NCT07500259
- Acronym / sponsor ID
- COLOPan / COLOPAN
- Keywords
- Drug profiling, Precision medicine, clinical validation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Luxembourg Institute of HealthOther government
- Collaborators
- Hopitaux Robert Schuman
- Study start
- 11 Sep 2026 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 1 Nov 2034 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRC | – | Other: Personalized Functional ProfilingParticipants are included while scheduled for biopsy or surgery of their colorectal cancer. |
| PDAC | – | Other: Personalized Functional ProfilingParticipants are included while scheduled for biopsy or surgery of their cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study targets patients undergoing surgery or biopsy at Hôpital Robert Schuman (HRS) in Luxembourg.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Functional ProfilingThis 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) | Other | CRC, PDAC |
Primary outcome
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.
2 secondary outcomes
Assessment of the exploratory value of PFP-derived functional profiles
Time frame: 0-5 years
Feasibility and Operational Evaluation of the PFP Platform
Time frame: 0-5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and PDAC - Pancreatic Ductal Adenocarcinoma, run by Luxembourg Institute of Health at 1 site in Luxembourg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Jun Kwon, phD (+352 26970-288, yong-jun.kwon@lih.lu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFP platform's predictive performance (time frame: 0-5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.