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

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ClinicalTrials.gov Identifier: NCT03997617
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Collaborators:
Integrated Biobank of Luxembourg
Laboratoire National de Santé (Luxembourg)
Centre Hospitalier du Luxembourg
Hopitaux Robert Schuman (Luxembourg)
Information provided by (Responsible Party):
Luxembourg Institute of Health

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.


Condition or disease Intervention/treatment Phase
Oncology Diagnostic Test: Personalized Functional Profiling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Number of patients for which a treatment recommendation for their specific cancer can be formulated, based on PFP [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Quantity of cells needed for the PFP analysis [ Time Frame: 4 weeks ]
  2. Duration of the PFP process for one specific patient [ Time Frame: 4 weeks ]
  3. Number of drugs recommended by using the PFP approach [ Time Frame: 4 weeks ]
  4. Number of patients for which the treatment recommendation issued by PFP were followed by the investigator [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997617


Contacts
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Contact: Guy Berchem, MD +35244112084 berchem.guy@chl.lu
Contact: Manon Gantenbein, PhD +35226970807 manon.gantenbein@lih.lu

Locations
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Luxembourg
Centre hospitalier de Luxembourg Recruiting
Luxembourg, Luxembourg, 1210
Contact: Guy Berchem, MD    +35244112084    berchem.guy@chl.lu   
Hôpitaux Robert Schmuan Recruiting
Luxembourg, Luxembourg, 2540
Contact: Marc Berna, MD    +352 (28) 88 6550    marc.berna@hopitauxschuman.lu   
Sponsors and Collaborators
Luxembourg Institute of Health
Integrated Biobank of Luxembourg
Laboratoire National de Santé (Luxembourg)
Centre Hospitalier du Luxembourg
Hopitaux Robert Schuman (Luxembourg)

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Responsible Party: Luxembourg Institute of Health
ClinicalTrials.gov Identifier: NCT03997617     History of Changes
Other Study ID Numbers: PFP-001
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Glioblastoma
Gastrointestinal Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases