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NCT Number: NCT01932489

The Jules Bordet Institute Molecular Profiling Program Feasibility Trial

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.

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Key information

Conditions

Colorectal Cancer Metastatic Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Melanoma Metastatic Melanoma Metastatic Non-Small Cell Lung Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jules Bordet Institute

Brussels, 1000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biopsy of a metastatic lesion.

Procedure

Primary outcomes

  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 outcomes

  1. Feasibility of a tumor sequencing board.

    Time frame: 2 months

    Ability of the "tumor sequencing board" to assign patients to ongoing clinical trials.

Sponsors and collaborators

Lead sponsor

Jules Bordet Institute

Other

Registry information

Official study title

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

Acronym: PRECISION-F

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 30, 2013
Registry last updated
May 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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