The Jules Bordet Institute Molecular Profiling Program Feasibility Trial

NCT ID: NCT01932489

Last Updated: 2018-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-10-31

Brief Summary

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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

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Conditions

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Colorectal Cancer Metastatic Metastatic Melanoma Metastatic Non-Small Cell Lung Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Sequencing of a metastatic lesion.

Biopsy of a metastatic lesion followed by a targeted cancer gene screen.

Group Type OTHER

Biopsy of a metastatic lesion.

Intervention Type PROCEDURE

Interventions

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Biopsy of a metastatic lesion.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jules Bordet Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Aftimos, MD

Role: PRINCIPAL_INVESTIGATOR

Jules Bordet Insitute

Locations

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Jules Bordet Institute

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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IJBCE2139

Identifier Type: -

Identifier Source: org_study_id

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