The Jules Bordet Institute Molecular Profiling Program Feasibility Trial

Metastatic Melanoma Clinical Trial

— PRECISION-F  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932489
• Other study ID #: IJBCE2139
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Jules Bordet Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Colorectal Cancer Metastatic
• Colorectal Neoplasms
• Lung Neoplasms
• Metastatic Melanoma
• Metastatic Non-Small Cell Lung Carcinoma

Intervention

Procedure:
• Biopsy of a metastatic lesion.

Locations

Country	Name	City	State
Belgium	Jules Bordet Institute	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Jules Bordet Institute

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Technical failure rate.	Frequency of failures of each pathological and molecular tests.	1 month
Primary	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	Feasibility of a tumor sequencing board.	Ability of the "tumor sequencing board" to assign patients to ongoing clinical trials.	2 months