Skip to main content
OpenTrials
Completed

NCT Number: NCT03997617

Personalized Functional Profiling in Metastatic Gastrointestinal Cancer or Recurrent Glioblastoma Patients in Luxembourg.

The investigators are developing a novel standardized and centralized approach named Integrated Personalized Functional Profiling (PFP) in Luxembourg. Based on recent improvements in cancer biopsy-derived 3D-culture technologies the PFP process will screen patient derived cells (PDCs) with FDA/EMA-approved drugs to generate personalized functional response profiles. The selected drug through PFP technology will provide personalized treatment recommendation for the patient.

This pilot study will evaluate the clinical feasibility of setting-up an effective workflow as a first step. Outcomes from this study will be used subsequently to help plan the clinical validation of the implementation of PFP.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Oncology Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier de Luxembourg, Luxembourg

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with recurrent Glioblastoma (rGBM) or with metastatic gastrointestinal cancer (mGIC), i.e. adenocarcinoma (any grade) of stomach, liver, pancreas, small intestine, colon, rectum
  • The patient has received previous cancer treatment for mGIC or rGBM
  • Male or female ≥ 18 years
  • Life expectancy ≥ 12 weeks
  • Histologically or cytologically confirmed diagnosis for mGIC or recurrence of a glioblastoma, WHO grade IV
  • For women of childbearing potential, a negative pregnancy test documented prior to the screening visit is required
  • Signed Inform Consent Form before any study related procedure

Exclusion criteria

  • For female patient, being pregnant, planning a pregnancy or breastfeeding
  • No fresh and viable tumor material available
  • Known active Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection
  • Uncontrolled medical conditions (i.e, diabetes mellitus, hypertension, etc), psychological, familial, sociological, or geographical conditions that do not allow compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol
  • In mGIC arm, patient with non-adenocarcinoma gastrointestinal cancer
  • Patient unable to understand and consent himself

Treatment and study plan

Personalized Functional Profiling

Diagnostic Test

During this pilot study, the overall goal of the project is to establish an effective workflow between the patient, the PFP platform, the clinician and return to the patient. This includes collection of the biopsy or surgery piece and standardized processing, dissociation, drug profiling and issuing treatment recommendation to the clinician. In case the clinician follows this treatment recommendation, patient management and follow up will be performed according to standard of care.

Primary outcomes

  1. Number of patients for which a treatment recommendation for their specific cancer can be formulated, based on PFP

    Time frame: 4 weeks

Secondary outcomes

  1. Quantity of cells needed for the PFP analysis

    Time frame: 4 weeks

  2. Duration of the PFP process for one specific patient

    Time frame: 4 weeks

  3. Number of drugs recommended by using the PFP approach

    Time frame: 4 weeks

  4. Number of patients for which the treatment recommendation issued by PFP were followed by the investigator

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Luxembourg Institute of Health

Other Gov

Collaborators

  • Centre Hospitalier du Luxembourg
  • Hopitaux Robert Schuman (Luxembourg)
  • Integrated Biobank of Luxembourg
  • Laboratoire National de Santé (Luxembourg)

Registry information

Official study title

Pilot Study to Explore the Integrated Personalized Functional Profiling (PFP) for Cancer Patients With Metastatic Gastrointestinal Cancer (mGIC) or Recurrent Glioblastoma (rGBM) in Luxembourg

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jun 25, 2019
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.