CompletedNCT03997617Updated Jun 13, 2025

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

An interventional study of Personalized Functional Profiling in Oncology, sponsored by Luxembourg Institute of Health. Completed at 2 sites in Luxembourg. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-13.

Sponsored by Luxembourg Institute of Health · Not applicable, Interventional, and Diagnostic

Phase: Not applicable
Study type: Interventional
Enrollment: 57
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

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.

Conditions studied

Oncology

Browse trials for

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 57 participants (actual)

Study arms

Other
Personalized Functional Profiling
Diagnostic Test: Personalized Functional Profiling

Interventions

Diagnostic testPersonalized Functional Profiling
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.

What researchers measure

Primary outcomes

Number of patients for which a treatment recommendation for their specific cancer can be formulated, based on PFP
Time frame: 4 weeks

Secondary outcomes

Quantity of cells needed for the PFP analysis
Time frame: 4 weeks
Duration of the PFP process for one specific patient
Time frame: 4 weeks
Number of drugs recommended by using the PFP approach
Time frame: 4 weeks
Number of patients for which the treatment recommendation issued by PFP were followed by the investigator
Time frame: 4 weeks

Study locations

2 sites

Centre hospitalier de Luxembourg
Luxembourg, 1210, Luxembourg
Hôpitaux Robert Schmuan
Luxembourg, 2540, Luxembourg

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT03997617
Lead sponsor: Luxembourg Institute of Health
Collaborators: Integrated Biobank of Luxembourg, Laboratoire National de Santé (Luxembourg), Centre Hospitalier du Luxembourg, Hopitaux Robert Schuman (Luxembourg)
Responsible party: Sponsor
First posted: Jun 25, 2019
Start date: Mar 11, 2019
Primary completion: Dec 31, 2024
Completion: Dec 31, 2024
Last update: Jun 13, 2025

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Glioblastoma→

Other studies from this sponsor

Luxembourg Institute of Health

Start the discussion