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

NCT03997617 | Completed DMC

• 1 other identifier: PFP-001
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Number of patients for which a treatment recommendation for their specific cancer can be formulated, based on PFP

  4 weeks

Secondary Outcomes (4)

• 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

Study Arms (1)

Personalized Functional Profiling

OTHER

Diagnostic Test: Personalized Functional Profiling

Interventions

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.

Personalized Functional Profiling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Luxembourg Institute of Health: lead
• Integrated Biobank of Luxembourg: collaborator
• Laboratoire National de Santé (Luxembourg): collaborator
• Centre Hospitalier du Luxembourg: collaborator
• Hopitaux Robert Schuman (Luxembourg): collaborator

Study Sites (2)

Centre hospitalier de Luxembourg

Luxembourg, Luxembourg, 1210, Luxembourg

Location

Hôpitaux Robert Schmuan

Luxembourg, Luxembourg, 2540, Luxembourg

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: June 25, 2019
• Study Start: March 11, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

LU (2)