Clinical trial NCT03997617: Personalized Functional Profiling in Metastatic Gastrointestinal Cancer or Recurrent Glioblastoma Patients in Luxembourg.
Official title: Pilot Study to Explore the Integrated Personalized Functional Profiling (PFP) for Cancer Patients With Metastatic Gastrointestinal Cancer (mGIC) or Recurrent Glioblastoma (rGBM) in Luxembourg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oncology
Lead sponsor: Luxembourg Institute of Health
Sponsor class: OTHER_GOV
Collaborators: name: Integrated Biobank of Luxembourg
name: Laboratoire National de Santé (Luxembourg)
name: Centre Hospitalier du Luxembourg
name: Hopitaux Robert Schuman (Luxembourg)
First posted: 2019-06-25
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Number of patients for which a treatment recommendation for their specific cancer can be formulated, based on PFP
timeFrame: 4 weeks
Secondary outcomes:
measure: Quantity of cells needed for the PFP analysis
timeFrame: 4 weeks
measure: Duration of the PFP process for one specific patient
timeFrame: 4 weeks
measure: Number of drugs recommended by using the PFP approach
timeFrame: 4 weeks
measure: Number of patients for which the treatment recommendation issued by PFP were followed by the investigator
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Luxembourg
country: Luxembourg
facility: Centre hospitalier de Luxembourg
city: Luxembourg
country: Luxembourg
facility: Hôpitaux Robert Schmuan
Study officials:
References: