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

NCT03997617 — Not applicable, Completed, 57 participants, Luxembourg Institute of Health

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

Registry	NCT03997617
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	57 (Actual)
Sponsor	Luxembourg Institute of Health (Other gov); collaborators: Integrated Biobank of Luxembourg, Laboratoire National de Santé (Luxembourg), Centre Hospitalier du Luxembourg, Hopitaux Robert Schuman (Luxembourg)
Conditions	Oncology
Interventions	Personalized Functional Profiling (Diagnostic test)
Dates	start 2019-03-11, primary completion 2024-12-31, completion 2024-12-31, first posted 2019-06-25, last updated 2025-06-13
Locations	2 sites in Luxembourg

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Personalized Functional Profiling	Other	Diagnostic Test: Personalized Functional Profiling

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.

+Outcome measures

Primary outcomes

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

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (2)

Facility	City	Country	Status
Centre hospitalier de Luxembourg	Luxembourg, Luxembourg	Luxembourg
Hôpitaux Robert Schmuan	Luxembourg, Luxembourg	Luxembourg

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