The Jules Bordet Institute Molecular Profiling Program Feasibility Trial (PRECISION-F)
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|ClinicalTrials.gov Identifier: NCT01932489|
Recruitment Status : Completed
First Posted : August 30, 2013
Last Update Posted : May 23, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic Metastatic Melanoma Metastatic Non-Small Cell Lung Carcinoma||Procedure: Biopsy of a metastatic lesion.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||THE JULES BORDET INSTITUTE PROGRAM FOR MOLECULAR PROFILING OF METASTATIC LESIONS: FEASIBILITY. PRECISION - Feasibility.|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Sequencing of a metastatic lesion.
Biopsy of a metastatic lesion followed by a targeted cancer gene screen.
Procedure: Biopsy of a metastatic lesion.
- Quality of the biopsies [ Time Frame: 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. [ Time Frame: 1 month ]Frequency of failures of each pathological and molecular tests.
- Percentage of patients with results within the specified turnaround time [ Time Frame: 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).
- Feasibility of a tumor sequencing board. [ Time Frame: 2 months ]Ability of the "tumor sequencing board" to assign patients to ongoing clinical trials.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932489
|Jules Bordet Institute|
|Brussels, Belgium, 1000|
|Principal Investigator:||Philippe Aftimos, MD||Jules Bordet Insitute|