The Jules Bordet Institute Molecular Profiling Program Feasibility Trial

Not Applicable

Completed

• Conditions: Metastatic Non-Small Cell Lung Carcinoma; Colorectal Cancer Metastatic; Metastatic Melanoma
• Interventions: Procedure: Biopsy of a metastatic lesion.

• Registration Number: NCT01932489
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-23
• Study First Submitted QC: 2013-08-27
• Study First Posted: 2013-08-30
• Study Start: 2013-12
• Status Verified: 2014-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2018-05-22
• Last Update Posted: 2018-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sequencing of a metastatic lesion.	Biopsy of a metastatic lesion.	Biopsy of a metastatic lesion followed by a targeted cancer gene screen.

Primary Outcome Measures

Name	Time	Method
Technical failure rate.	1 month	Frequency of failures of each pathological and molecular tests.
Quality of the biopsies	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.
Percentage of patients with results within the specified turnaround time	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

Name	Time	Method
Feasibility of a tumor sequencing board.	2 months	Ability of the "tumor sequencing board" to assign patients to ongoing clinical trials.

Trial Locations

Locations (1)

Jules Bordet Institute; 🇧🇪 Brussels, Belgium