The Jules Bordet Institute Molecular Profiling Program Feasibility Trial

Study Overview
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Brief Summary
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Prior to the use of genomic tests for patient inclusion in clinical trials, it is essential for the Jules Bordet Institute (JBI) to pilot the logistical and technical aspects by examining the feasibility and turnaround time of performing and obtaining data from a few key molecular assays. Patients with metastatic colorectal cancer, non-small cell lung cancer or melanoma will be enrolled. Biopsie from metastatic lesions will be performed. A targeted cancer gene screen assay will be performed using DNA sequencing. Results will be discussed during a molecular screening tumor board.

Official Title
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THE JULES BORDET INSTITUTE PROGRAM FOR MOLECULAR PROFILING OF METASTATIC LESIONS: FEASIBILITY. PRECISION - Feasibility.

Conditions
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Colorectal Cancer Metastatic, Metastatic Melanoma, Metastatic Non-Small Cell Lung Carcinoma

Intervention / Treatment
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* Procedure: Biopsy of a metastatic lesion.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent for all study procedures according to local regulatory requirements prior to enrollment into the study. Age ≥ 18 years. Histologically proven metastatic or locally recurrent CRC, NSCLC or melanoma. Tumor tissue (FFPE and frozen) from recurrent or metastatic lesions available for research purposes. Exclusion Criteria: Eastern Cooperative Oncology Group (ECOG) Performance Status >2. The biopsy procedure is estimated to be too risky for the patient. Any anti-VEGF or anti-VEGFR treatment administered less than 3 weeks before new biopsy procedure. No appropriate washout period for patients on anticoagulation therapy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sequencing of a metastatic lesion.<br>Biopsy of a metastatic lesion followed by a targeted cancer gene screen. | Procedure: Biopsy of a metastatic lesion.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of the biopsies | Percentage of frozen and FFPE core biopsies that are able to provide at least 1.5 μg of DNA of high quality suitable for molecular testing. | 1 month | 
| Technical failure rate. | Frequency of failures of each pathological and molecular tests. | 1 month | 
| Percentage of patients with results within the specified turnaround time | Percentage of patients for whom biopsy was performed within 10 working days from signature of the ICF and for whom all central laboratory results (pathology and molecular) will be available to the investigator within 15 working days from the time samples are received at the central laboratory (JBI). | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of a tumor sequencing board. | Ability of the tumor sequencing board to assign patients to ongoing clinical trials. | 2 months |