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

Primary Purpose

Oncology

Status
Recruiting
Phase
Not Applicable
Locations
Luxembourg
Study Type
Interventional
Intervention
Personalized Functional Profiling
Sponsored by
Luxembourg Institute of Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Oncology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre hospitalier de LuxembourgRecruiting
  • Hôpitaux Robert SchmuanRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Personalized Functional Profiling

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 11, 2019
Last Updated
March 13, 2023
Sponsor
Luxembourg Institute of Health
Collaborators
Integrated Biobank of Luxembourg, Laboratoire National de Santé (Luxembourg), Centre Hospitalier du Luxembourg, Hopitaux Robert Schuman (Luxembourg)
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1. Study Identification

Unique Protocol Identification Number
NCT03997617
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Luxembourg Institute of Health
Collaborators
Integrated Biobank of Luxembourg, Laboratoire National de Santé (Luxembourg), Centre Hospitalier du Luxembourg, Hopitaux Robert Schuman (Luxembourg)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oncology

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Personalized Functional Profiling
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Personalized Functional Profiling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients for which a treatment recommendation for their specific cancer can be formulated, based on PFP
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Quantity of cells needed for the PFP analysis
Time Frame
4 weeks
Title
Duration of the PFP process for one specific patient
Time Frame
4 weeks
Title
Number of drugs recommended by using the PFP approach
Time Frame
4 weeks
Title
Number of patients for which the treatment recommendation issued by PFP were followed by the investigator
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guy Berchem, MD
Phone
+35244112084
Email
berchem.guy@chl.lu
First Name & Middle Initial & Last Name or Official Title & Degree
Manon Gantenbein, PhD
Phone
+35226970807
Email
manon.gantenbein@lih.lu
Facility Information:
Facility Name
Centre hospitalier de Luxembourg
City
Luxembourg
ZIP/Postal Code
1210
Country
Luxembourg
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guy Berchem, MD
Phone
+35244112084
Email
berchem.guy@chl.lu
Facility Name
Hôpitaux Robert Schmuan
City
Luxembourg
ZIP/Postal Code
2540
Country
Luxembourg
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Berna, MD
Phone
+352 (28) 88 6550
Email
marc.berna@hopitauxschuman.lu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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