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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequencing of a metastatic lesion. | Other | Biopsy of a metastatic lesion followed by a targeted cancer gene screen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy of a metastatic lesion. | Procedure |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Aftimos, MD | Jules Bordet Insitute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jules Bordet Institute | Brussels | 1000 | Belgium |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |