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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
Sponsor:
Information provided by (Responsible Party):
Jules Bordet Institute

Tracking Information
First Submitted Date  ICMJE August 23, 2013
First Posted Date  ICMJE August 30, 2013
Last Update Posted Date May 23, 2018
Study Start Date  ICMJE December 2013
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2013)
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01932489 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2013)
Feasibility of a tumor sequencing board. [ Time Frame: 2 months ]
Ability of the "tumor sequencing board" to assign patients to ongoing clinical trials.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Jules Bordet Institute Molecular Profiling Program Feasibility Trial
Official Title  ICMJE THE JULES BORDET INSTITUTE PROGRAM FOR MOLECULAR PROFILING OF METASTATIC LESIONS: FEASIBILITY. PRECISION - Feasibility.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Colorectal Cancer Metastatic
  • Metastatic Melanoma
  • Metastatic Non-Small Cell Lung Carcinoma
Intervention  ICMJE Procedure: Biopsy of a metastatic lesion.
Study Arms  ICMJE Sequencing of a metastatic lesion.
Biopsy of a metastatic lesion followed by a targeted cancer gene screen.
Intervention: Procedure: Biopsy of a metastatic lesion.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2014)
35
Original Estimated Enrollment  ICMJE
 (submitted: August 27, 2013)
30
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01932489
Other Study ID Numbers  ICMJE IJBCE2139
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jules Bordet Institute
Study Sponsor  ICMJE Jules Bordet Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philippe Aftimos, MD Jules Bordet Insitute
PRS Account Jules Bordet Institute
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP