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出境医 / 临床实验 / Personalized Functional Profiling in Metastatic Gastrointestinal Cancer or Recurrent Glioblastoma Patients in Luxembourg.
Personalized Functional Profiling in Metastatic Gastrointestinal Cancer or Recurrent Glioblastoma Patients in Luxembourg.
Study Description
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 |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | N/A |
| 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 : | December 1, 2021 |
| Estimated Study Completion Date : | March 30, 2022 |
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures :
- 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 :
- Quantity of cells needed for the PFP analysis [ Time Frame: 4 weeks ]
- Duration of the PFP process for one specific patient [ Time Frame: 4 weeks ]
- Number of drugs recommended by using the PFP approach [ Time Frame: 4 weeks ]
- Number of patients for which the treatment recommendation issued by PFP were followed by the investigator [ Time Frame: 4 weeks ]
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| Contact: Guy Berchem, MD | +35244112084 | berchem.guy@chl.lu | |
| Contact: Manon Gantenbein, PhD | +35226970807 | manon.gantenbein@lih.lu |
Locations
| 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)
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | March 11, 2019 | ||||||||
| First Posted Date ICMJE | June 25, 2019 | ||||||||
| Last Update Posted Date | January 15, 2021 | ||||||||
| Actual Study Start Date ICMJE | March 11, 2019 | ||||||||
| Estimated Primary Completion Date | December 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Number of patients for which a treatment recommendation for their specific cancer can be formulated, based on PFP [ Time Frame: 4 weeks ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Personalized Functional Profiling in Metastatic Gastrointestinal Cancer or Recurrent Glioblastoma Patients in Luxembourg. | ||||||||
| Official Title ICMJE | Pilot Study to Explore the Integrated Personalized Functional Profiling (PFP) for Cancer Patients With Metastatic Gastrointestinal Cancer (mGIC) or Recurrent Glioblastoma (rGBM) in Luxembourg | ||||||||
| 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. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
||||||||
| Condition ICMJE | Oncology | ||||||||
| Intervention ICMJE | 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.
|
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| Study Arms ICMJE | Personalized Functional Profiling
Intervention: Diagnostic Test: Personalized Functional Profiling
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
20 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | March 30, 2022 | ||||||||
| Estimated Primary Completion Date | December 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Luxembourg | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03997617 | ||||||||
| Other Study ID Numbers ICMJE | PFP-001 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Luxembourg Institute of Health | ||||||||
| Study Sponsor ICMJE | Luxembourg Institute of Health | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Luxembourg Institute of Health | ||||||||
| Verification Date | January 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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