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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

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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Sequencing of a metastatic lesion.
Biopsy of a metastatic lesion followed by a targeted cancer gene screen.
Procedure: Biopsy of a metastatic lesion.



Primary Outcome Measures :
  1. 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.

  2. Technical failure rate. [ Time Frame: 1 month ]
    Frequency of failures of each pathological and molecular tests.

  3. 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).


Secondary Outcome Measures :
  1. Feasibility of a tumor sequencing board. [ Time Frame: 2 months ]
    Ability of the "tumor sequencing board" to assign patients to ongoing clinical trials.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Belgium
Jules Bordet Institute
Brussels, Belgium, 1000
Sponsors and Collaborators
Jules Bordet Institute
Investigators
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Principal Investigator: Philippe Aftimos, MD Jules Bordet Insitute

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Responsible Party: Jules Bordet Institute
ClinicalTrials.gov Identifier: NCT01932489     History of Changes
Other Study ID Numbers: IJBCE2139
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: October 2014

Additional relevant MeSH terms:
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Colorectal Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms