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

Oncology Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03997617
• Other study ID #: PFP-001
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2019
• Est. completion date: July 31, 2024

Study information

• Verified date: March 2023
• Source: Luxembourg Institute of Health
• Contact: Guy Berchem, MD
• Phone: +35244112084
• Email: berchem.guy[@]chl.lu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Neoplasms
• Glioblastoma
• Oncology

Intervention

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.

Locations

Country	Name	City	State
Luxembourg	Centre hospitalier de Luxembourg	Luxembourg
Luxembourg	Hôpitaux Robert Schmuan	Luxembourg

Sponsors (5)

Lead Sponsor	Collaborator
Luxembourg Institute of Health	Centre Hospitalier du Luxembourg, Hopitaux Robert Schuman (Luxembourg), Integrated Biobank of Luxembourg, Laboratoire National de Santé (Luxembourg)

Country where clinical trial is conducted

Luxembourg, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients for which a treatment recommendation for their specific cancer can be formulated, based on PFP		4 weeks
Secondary	Quantity of cells needed for the PFP analysis		4 weeks
Secondary	Duration of the PFP process for one specific patient		4 weeks
Secondary	Number of drugs recommended by using the PFP approach		4 weeks
Secondary	Number of patients for which the treatment recommendation issued by PFP were followed by the investigator		4 weeks