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

ConditionsColorectal CancerPDAC - Pancreatic Ductal Adenocarcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLuxembourg Institute of Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Personalized Functional Profiling

    Other intervention

    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)

Treatment groups

188 Participants
are divided into 2 treatment groups
Group A: CRC1 intervention
Group B: PDAC1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Luxembourg Institute of Health

Lead sponsor

Hopitaux Robert Schuman

Collaborator

Source ClinicalTrials.gov
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