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

Luxembourg Institute of Health

Status

Completed

Conditions

Oncology

Treatments

Diagnostic Test: Personalized Functional Profiling

Study type

Interventional

Funder types

Other

Identifiers

NCT03997617

PFP-001

Details and patient eligibility

About

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.

Enrollment

57 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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