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

  • STATUS
    Recruiting
  • End date
    Jul 31, 2023
  • participants needed
    20
  • sponsor
    Luxembourg Institute of Health
Updated on 16 March 2022
cancer treatment
glioblastoma multiforme

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.

Details
Condition Oncology
Treatment Personalized Functional Profiling
Clinical Study IdentifierNCT03997617
SponsorLuxembourg Institute of Health
Last Modified on16 March 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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