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

Not Applicable

Recruiting

• Conditions: Oncology
• Interventions: Diagnostic Test: Personalized Functional Profiling

• Registration Number: NCT03997617
• Lead Sponsor: Luxembourg Institute of Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-11
• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-06-24
• Study First Posted: 2019-06-25
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-13
• Primary Completion: 2025-12-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Personalized Functional Profiling	Personalized Functional Profiling	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Centre hospitalier de Luxembourg; 🇱🇺 Luxembourg, Luxembourg

Hôpitaux Robert Schmuan; 🇱🇺 Luxembourg, Luxembourg