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The Jules Bordet Institute Molecular Profiling Program Feasibility Trial (PRECISION-F)

F

Free University of Brussels (ULB)

Status

Completed

Conditions

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

Treatments

Procedure: Biopsy of a metastatic lesion.

Study type

Interventional

Funder types

Other

Identifiers

NCT01932489
IJBCE2139

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 1 patient group

Sequencing of a metastatic lesion.
Other group
Description:
Biopsy of a metastatic lesion followed by a targeted cancer gene screen.
Treatment:
Procedure: Biopsy of a metastatic lesion.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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