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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03997617
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Luxembourg Institute of Health
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Luxembourg
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Oncology

Arms & Interventions

Arms

Other: Personalized Functional Profiling

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Centre hospitalier de Luxembourg, Luxembourg, Luxembourg

Status

Recruiting

Address

Centre hospitalier de Luxembourg

Luxembourg, , 1210

Site Contact

Guy Berchem, MD

[email protected]

+35244112084

Hôpitaux Robert Schmuan, Luxembourg, Luxembourg