The Jules Bordet Institute Molecular Profiling Program Feasibility Trial (PRECISION-F)

May 22, 2018 updated by: Jules Bordet Institute

THE JULES BORDET INSTITUTE PROGRAM FOR MOLECULAR PROFILING OF METASTATIC LESIONS: FEASIBILITY. PRECISION - Feasibility.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • Jules Bordet Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sequencing of a metastatic lesion.
Biopsy of a metastatic lesion followed by a targeted cancer gene screen.
Procedure: Biopsy of a metastatic lesion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month
Technical failure rate.
Time Frame: 1 month
Frequency of failures of each pathological and molecular tests.
1 month
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).
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of a tumor sequencing board.
Time Frame: 2 months
Ability of the "tumor sequencing board" to assign patients to ongoing clinical trials.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jules Bordet Institute

Investigators

  • Principal Investigator: Philippe Aftimos, MD, Jules Bordet Insitute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

August 23, 2013

First Submitted That Met QC Criteria

August 27, 2013

First Posted (Estimate)

August 30, 2013

Study Record Updates

Last Update Posted (Actual)

May 23, 2018

Last Update Submitted That Met QC Criteria

May 22, 2018

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IJBCE2139

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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