ClinicalTrials.gg
RecruitingNCT07500259COLOPanUpdated Sep 15, 2026

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

An observational study in Colorectal Cancer and PDAC - Pancreatic Ductal Adenocarcinoma, sponsored by Luxembourg Institute of Health. Recruiting at 1 site in Luxembourg. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Luxembourg Institute of Health · Observational

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
188
Ages
18 Years and older
Sex
All
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Study 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.

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.

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Conditions studied

  • Colorectal Cancer
  • PDAC - Pancreatic Ductal Adenocarcinoma

Keywords

  • Drug profiling
  • Precision medicine
  • clinical validation
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In context

Colorectal Neoplasms

6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.

This study's planned enrollment of 188 is below the median of 250 across 1,440 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Luxembourg Institute of Health is the lead sponsor of 28 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Signed 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 (primary tumour or ) PDAC

Exclusion criteria

Exclusion Criteria:

  • Female patient, pregnant, planning a pregnancy or breastfeeding.
  • Known active (HIV), Virus (HBV), or Virus (HCV) infection.
  • Patient unable to understand and provide and has no family member representing him/her.
  • Patients with any other life-threatening illness, significant organ dysfunction or any conditions that, according to the hospital physician, could compromise the patient's safety.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
188 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • OtherPersonalized 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)

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What researchers measure

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.

    Time frame: 0-5 years

Secondary outcomes

  1. Assessment of the exploratory value of PFP-derived functional profiles

    Correlation between the ex vivo drug sensitivity data and observed clinical outcomes

    Time frame: 0-5 years

  2. 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.

    Time frame: 0-5 years

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Study locations

1 of 1 sites recruiting
  • Hôpitaux Robert Schmuan
    Luxembourg, Luxembourg 2540, Luxembourg
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Informed consent form

Time frame: Data will be made available for collaboration after publication

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Sep 2029, 36 months after the start.

Of 528 non-industry observational studies under Colorectal Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 132. This study's planned 36 months is below that.

Counting every sponsor, half of 645 studies reached it within 51 months; a quarter within 27 and three quarters within 104.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 24, 2026
First posted
Mar 30, 2026
StartActual
Sep 11, 2026
Primary completionEst.
Sep 30, 2029
CompletionEst.
Nov 1, 2034
Last update
Sep 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07500259
Lead sponsor
Luxembourg Institute of Health
Collaborators
Hopitaux Robert Schuman
Responsible party
Sponsor
First posted
Mar 30, 2026
Start date
Sep 11, 2026
Primary completion
Sep 30, 2029 (estimated)
Completion
Nov 1, 2034 (estimated)
Last update
Sep 15, 2026

Study contacts

Yong Jun Kwon, phD
Contact
yong-jun.kwon@lih.lu
+352 26970-288

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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