The Jules Bordet Institute Molecular Profiling Program Feasibility Trial

NCT01932489 | Completed

• 1 other identifier: IJBCE2139
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Quality of the biopsies

  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.

  Frequency of failures of each pathological and molecular tests.

  1 month

• Percentage of patients with results within the specified turnaround time

  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 Outcomes (1)

• Feasibility of a tumor sequencing board.

  2 months

Study Arms (1)

Sequencing of a metastatic lesion.

OTHER

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

Procedure: Biopsy of a metastatic lesion.

Interventions

Biopsy of a metastatic lesion. PROCEDURE

Sequencing of a metastatic lesion.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Jules Bordet Institute

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Melanoma; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Philippe Aftimos, MD

  Jules Bordet Insitute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2013
• First Posted: August 30, 2013
• Study Start: December 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: May 23, 2018

Record last verified: 2014-10

Locations

BE (1)