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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Oncology

Intervention / Treatment
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* Diagnostic Test: Personalized Functional Profiling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Personalized Functional Profiling<br> | Diagnostic Test: Personalized Functional Profiling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients for which a treatment recommendation for their specific cancer can be formulated, based on PFP |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |