The Jules Bordet Institute Molecular Profiling Program Feasibility Trial
PRECISION-F
THE JULES BORDET INSTITUTE PROGRAM FOR MOLECULAR PROFILING OF METASTATIC LESIONS: FEASIBILITY. PRECISION - Feasibility.
PRECISION-F
THE JULES BORDET INSTITUTE PROGRAM FOR MOLECULAR PROFILING OF METASTATIC LESIONS: FEASIBILITY. PRECISION - Feasibility.
Sponsor study identifier
interventional
35
1 country
1
Study Start
December 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2014
Actual (reported)Study Completion
October 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 23, 2013
Actual (reported)August 30, 2013
Actual (reported)December 2013
Date type not reportedThis date has not been verified as actual or estimated.
October 2014
Actual (reported)October 2014
Actual (reported)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
Feasibility of a tumor sequencing board.
2 months
Biopsy of a metastatic lesion followed by a targeted cancer gene screen.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Jules Bordet Institute
Brussels, 1000, Belgium
Philippe Aftimos, MD
Jules Bordet Insitute
35 participants (actual enrollment reported by the registry).
First Submitted
August 23, 2013
First Posted
August 30, 2013
Study Start
December 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
October 2014
Actual (reported)Study Completion
October 2014
Actual (reported)Last Updated
May 23, 2018
Record last verified: 2014-10
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Source: ClinicalTrials.gov.
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