In short
The PRECISION initiative follows the Next-Generation Sequencing pilot study, which investigated the feasibility of using Next-Generation Sequencing (NGS) in routine clinical diagnostics for (hemo)oncology in Belgium. Hemato-oncology focuses on the study, diagnosis, and treatment of malignant disorders of the blood and bone marrow. NGS is an advanced and complex technique capable of sequencing and analysing large quantities of DNA and RNA at high speeds, allowing for precise and rapid detection of gene(s) alterations in cancer cells in a single test.
The Precision Belgium initiative, known as “The Belgian Molecular Profiling Program of Metastatic Cancer for Clinical Decision and Treatment Assignment” is initiated by the Belgian Society of Medical Oncology (BSMO) and coordinated by Sciensano. Its aim is to expand genotype-based targeted cancer treatments beyond strictly registered disease associated contexts.
All health data, clinical and molecular, acquired in the different pillars of the precision initiative are stored in the Precision Belgium section of the Healthdata database, a national platform developed by Sciensano to collect and store the citizens’ health data in a secure and uniform manner.
Project description
PRECISION is an initiative from the Belgian Society of Medical Oncology (BSMO) in collaboration with several stakeholders, encompassing four programs that aim to boost genomic and clinical knowledge with the ultimate goal to offer patients with metastatic solid tumors molecularly guided treatments. This initiative comprises several studies: PRECISION 1, GeNeo, Ballett and PRECISION 2. The PRECISION 1 study has led to the creation of a clinicogenomic database. The Belgian Approach for Local Laboratory Extensive Tumor Testing (BALLETT) and GeNeo studies aim to expand the population of patients with advanced cancer who undergo thorough genotyping of their tumors . The PRECISION 2 project consists of investigator-initiated phase II studies aiming to provide access to a targeted drug for patients whose tumors harbor actionable mutations in case the matched drug is not available through reimbursement or clinical trials in Belgium.
1.GENEO: A study to examine the value of broad agnostic NGS panel testing versus reimbursed organ-directed NGS: a Belgian Precision study of the BSMO in collaboration with the Cancer Centre
In the GeNeo study, the goal was to sequence 1000 metastatic (or locally advanced) cancer patients with the Roche- Foundation Medicine (FMI) comprehensive gene panel (324 genes). Based on the results of this comprehensive gene profiling, a national molecular tumor board (nMTB) of experts recommended the best treatment option for each patient. The proportion of patients with an actionable alteration and matched therapy or clinical trial, and the uptake of the MTB recommended treatment have been evaluated.
Duration: 01/10/2020 — 20/12/2022
Multicentric: 13 Belgian hospitals
Study partners: Roche Pharma — FMI, Sciensano Cancer Center & Healthdata
2. BALLETT: Belgian Approach for Local Laboratory Extensive Tumor Testing: A study to examine the clinical value of comprehensive genomic profiling performed by Belgian NGS laboratories: a Belgian Precision study of the BSMO in collaboration with the Cancer Centre
The aim of this nationwide multicentric project is to examine the clinical value of comprehensive genomic profiling (CGP) in real-life clinical practice in Belgium. CGP testing was applied to 870 metastatic cancer patients recruited in 12 Belgian hospitals and performed in a decentralized but fully standardized way in 9 Belgian NGS-laboratories. A national molecular tumor board (nMTB) of experts recommended the best treatment option for each patient guided by the CGP results. The proportion of patients with an actionable alteration and matched therapy or clinical trial, and the uptake of the MTB recommended treatment are being evaluated. The ultimate goals were to increase therapeutic options, improve patient outcomes, secure CGP reimbursement and increase attractiveness of Belgium for clinical trials.
Duration: 29/03/2021- June 2023 (recruitment is closed)
Status: Analysis is ongoing
Multicentric: 12 Belgian hospitals
CGP testing is done in 9 Belgian laboratories
Study partners: Illumina, oncoDNA , PerianDx and Sciensano — Cancer Center & Healthdata
3. PRECISION 1
The aim of the PRECISION 1 study was to create cross-platform collaborations to enable the sharing of NGS sequences and clinical data as well as to collect the molecular profiling data of patients recruited and tested in GeNeo and BALLETT studies. The patients treatments were followed up over the period of 3 years.
4. PRECISION 2
Precision 2 organises exploratory phase 2 studies in genotypes for which there are no validated therapies available nor genotype-based clinical trials that are currently running. A national strategy of systematic genomic characterisation of patients with metastatic cancer (PRECISION 1 and the NGS pilot study) may stimulate the implementation of new genotype-based clinical studies and make Belgian centres more attractive for studies with new or targeted treatments. It is an opportunity for patients to be included more easily in clinical trials with new drugs with a potentially high impact.
The PRECISION 2 clinical trials:
Open explorative phase II, open label study of Afatinib in the treatment of advanced cancer carrying an EGFR, a HER2 or a HER3 mutation followed by the addition of paclitaxel to Afatinib at disease progression
Duration: 27/10/2017 – 13/12/2022
Multicentric: 9 Belgian hospitals
Pharma study partner: Boehringer Ingelheim International GmbH
Efficacy of Olaparib in advanced cancers occurring in patients with germline mutations or somatic tumor mutations in homologous recombination genes (HRD)
Start date: 07/02/2019 – 31/12/2024
Multicentric: 12 Belgian hospitals
Pharma study partner: AstraZeneca
Sciensano's project investigator(s):
Service(s) working on this project
Partners
