ClinicalTrials.gg
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
01

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.

02

Conditions studied

  • Oncology

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03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's enrollment of 57 is close to the median of 60 across 7,703 interventional studies indexed under Neoplasms.

Browse 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.

04

Who can participate

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

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

  • Patient with recurrent Glioblastoma (rGBM) or with 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
  • ≥ 12 weeks
  • or cytologically confirmed diagnosis for mGIC or recurrence of a glioblastoma, WHO grade IV
  • For women of , 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 (HIV), Virus (HBV), or 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
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.

Metastases

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

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

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.

05

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.

06

What researchers measure

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

07

Study locations

2 sites
  • Centre hospitalier de Luxembourg
    Luxembourg, 1210, Luxembourg
  • Hôpitaux Robert Schmuan
    Luxembourg, 2540, Luxembourg
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

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

Ran from Mar 2019 to primary completion in Dec 2024, 69 months.

Of 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's 69 months is above that.

Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

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

Registered
Mar 11, 2019
First posted
Jun 25, 2019
StartActual
Mar 11, 2019
Primary completionActual
Dec 31, 2024
CompletionActual
Dec 31, 2024
Last update
Jun 13, 2025
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 Jun 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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.

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