Back to resultsThe Jules Bordet Institute Molecular Profiling Program Feasibility Trial (PRECISION-F)
Primary Purpose
Colorectal Cancer Metastatic, Metastatic Melanoma, Metastatic Non-Small Cell Lung Carcinoma
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Biopsy of a metastatic lesion.
Sponsored by
About this trial
This is an interventional other trial for Colorectal Cancer Metastatic
Eligibility Criteria
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.
Sites / Locations
- Jules Bordet Institute
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Sequencing of a metastatic lesion.
Arm Description
Biopsy of a metastatic lesion followed by a targeted cancer gene screen.
Outcomes
Primary Outcome Measures
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.
Technical failure rate.
Frequency of failures of each pathological and molecular tests.
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).
Secondary Outcome Measures
Feasibility of a tumor sequencing board.
Ability of the "tumor sequencing board" to assign patients to ongoing clinical trials.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01932489
Brief Title
The Jules Bordet Institute Molecular Profiling Program Feasibility Trial
Acronym
PRECISION-F
Official Title
THE JULES BORDET INSTITUTE PROGRAM FOR MOLECULAR PROFILING OF METASTATIC LESIONS: FEASIBILITY. PRECISION - Feasibility.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jules Bordet Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Metastatic, Metastatic Melanoma, Metastatic Non-Small Cell Lung Carcinoma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequencing of a metastatic lesion.
Arm Type
Other
Arm Description
Biopsy of a metastatic lesion followed by a targeted cancer gene screen.
Intervention Type
Procedure
Intervention Name(s)
Biopsy of a metastatic lesion.
Primary Outcome Measure Information:
Title
Quality of the biopsies
Description
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.
Time Frame
1 month
Title
Technical failure rate.
Description
Frequency of failures of each pathological and molecular tests.
Time Frame
1 month
Title
Percentage of patients with results within the specified turnaround time
Description
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).
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Feasibility of a tumor sequencing board.
Description
Ability of the "tumor sequencing board" to assign patients to ongoing clinical trials.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Aftimos, MD
Organizational Affiliation
Jules Bordet Insitute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jules Bordet Institute
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
The Jules Bordet Institute Molecular Profiling Program Feasibility Trial
We'll reach out to this number within 24 hrs