Colorectal Cancer Metastatic, Metastatic Melanoma, Metastatic Non-Small Cell Lung Carcinoma
Conditions
Brief summary
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.
Interventions
PROCEDUREBiopsy of a metastatic lesion.
Sponsors
Jules Bordet Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of the biopsies | 1 month | 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. |
| Technical failure rate. | 1 month | Frequency of failures of each pathological and molecular tests. |
| Percentage of patients with results within the specified turnaround time | 1 month | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of a tumor sequencing board. | 2 months | Ability of the tumor sequencing board to assign patients to ongoing clinical trials. |
Countries
Belgium
Outcome results
None listed