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

March 13, 2023 updated by: Luxembourg Institute of Health

Pilot Study to Explore the Integrated Personalized Functional Profiling (PFP) for Cancer Patients With Metastatic Gastrointestinal Cancer (mGIC) or Recurrent Glioblastoma (rGBM) in Luxembourg

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Luxembourg
      • Luxembourg, Luxembourg, 1210
        • Recruiting
        • Centre Hospitalier de Luxembourg
        • Contact:
      • Luxembourg, Luxembourg, 2540

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Personalized Functional Profiling
Diagnostic test: Personalized Functional Profiling
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients for which a treatment recommendation for their specific cancer can be formulated, based on PFP
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luxembourg Institute of Health

Collaborators

Integrated Biobank of Luxembourg
Centre Hospitalier du Luxembourg
Laboratoire National de Santé (Luxembourg)
Hopitaux Robert Schuman (Luxembourg)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2019

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

July 31, 2024

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

June 24, 2019

First Posted (Actual)

June 25, 2019

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PFP-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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