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

NCT ID: NCT03997617

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-11
• Study Completion Date: 2024-12-31

Brief 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

Oncology

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Personalized Functional Profiling

Group Type: OTHER

Personalized Functional Profiling

Intervention Type: 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.

Interventions

Personalized 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Integrated Biobank of Luxembourg

OTHER

Sponsor Role: collaborator

Laboratoire National de Santé (Luxembourg)

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier du Luxembourg

OTHER

Sponsor Role: collaborator

Hopitaux Robert Schuman (Luxembourg)

UNKNOWN

Sponsor Role: collaborator

Luxembourg Institute of Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre hospitalier de Luxembourg

Luxembourg, Luxembourg, Luxembourg

Hôpitaux Robert Schmuan

Luxembourg, Luxembourg, Luxembourg

Countries

Luxembourg

Other Identifiers

PFP-001

Identifier Type: -

Identifier Source: org_study_id