Belgian Molecular Profiling program of metastatic cancer for clinical decision and treatment assignment

Although many types of cancer treatments exist, sound decision strategies as to which treatment is the most suitable for a cancer patient are scarce. Also, with the advent of the Next Generation Sequencing (NGS) technology in the Belgian healthcare landscape, opportunities especially arise for genomic criteria to be included in the cancer treatment decision strategy.

PRECISION aims to link patients with specific cancer genotypes to matched cancer treatments. Advices from each of the university hospital’s local Medical Advisory Board (MAB) as well as from the central MAB will be collected and shared across the data providers.

Data and Resources

General Hospitals

Laboratory Workers

National Institute for Health and Disability Insurance

Physicians

Field	Value
Modified	2020-07-21
Release Date	2018-03-27
Identifier	0e041975-8578-4cc6-b284-2fcbbaeafc96
License	Creative Commons Attribution
Public Access Level	Public

Protocol

Protocol
Full title of the project	Belgian Molecular Profiling program of metastatic cancer for clinical decision and treatment assignment
Name or abbreviated title of the project where available	PRECISION Belgium
Source type	Patient registries

Sponsor(s)

Primary organization that oversees implementation of study and is responsible for data analysis.
Name of organisation	Belgian Society of Medical Oncology

Commissioner(s)

Organisation that commissioned this project
Name of organisation	Belgian Society of Medical Oncology

Source(s) of Monetary or Material Support

Organisation (1) providing support
Name of organisation (1)	National Institute for Health and Disability Insurance
Website(s) of organisation (1)	Website

Organisation (2) providing support
Name of organisation (2)	Belgian Society of Medical Oncology

Governance

Governance
Is there a Steering / Accompanying committee?	Yes

General information

General information
Project description	Although many types of cancer treatments exist, sound decision strategies as to which treatment is the most suitable for a cancer patient are scarce. Also, with the advent of the Next Generation Sequencing (NGS) technology in the Belgian healthcare landscape, opportunities especially arise for genomic criteria to be included in the cancer treatment decision strategy. PRECISION aims to link patients with specific cancer genotypes to matched cancer treatments. Advices from each of the university hospital’s local Medical Advisory Board (MAB) as well as from the central MAB will be collected and shared across the data providers.

Therapeutic area
Disease	Cancer

Objective of the project
Main objective of the project	The overall aim of PRECISION is to understand the genetic mechanisms of sensitivity to targeted and other anticancer therapies. This may improve patient selection, response to therapy, and rational treatment designs. To do so, PRECISION aims to establish an inter-platform cooperation and sequencing quality control as well as to examine the feasibility and efficiency of using information coming out of this effort to direct patients to existing genotype-based clinical trials (PRECISION 1) or start new genotype-driven clinical trials for identified actionable genetic alterations if no trials are available yet (PRECISION 2).
Public health relevance of project	For the patients this project creates an opportunity to be identified much more easily as being eligible for inclusion in trials with new potentially high impact drugs, while this is very difficult to achieve if genomic characterization needs to be performed at hoc.
Scientific relevance of the project	Precision oncology defines an approach to personalized medicine, using technologic advances in genomics and molecular profiling of tumors and individuals, and mechanism-based therapeutics to enhance clinical outcomes and encourage successful translational research. Determining whether rare aberrations are drivers (oncogenic contributors) or just passengers (clonally propagated with neutral effect) and whether they are clinically actionable will require further functional evaluation as well as the analysis of clinical data.
Additional information	No additional information available

Legal basis

Type of legal basis
Type of legal basis	Unknown

Design of the project

Principal inclusion and exclusion criteria
Principal inclusion criteria	Patients with metastatic solid tumors that are candidates for systemic therapy; Patient showing an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2; Patients able to provide written informed consent prior to enrollment into a subsequent clinical trial; Patients agree to provide archival biopsy (or surgery) samples, either FFPE and/or frozen, preferably from metastatic sites or the primary tumor or samples from new biopsies in order to perform a targeted gene panel sequencing; Patients agree to provide a blood sample for DNA sequencing. Patients have signed an informed consent for the study and an informed consent for the genomic analysis of their germ-line DNA
Principal exclusion criteria	Life expectancy of less than 12 weeks; Inability to comply with protocol procedures; Known presence of severe hematopoietic, renal, and/or hepatic dysfunction (according to the local PI); Previous or current other malignancies within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin. Patients with bone-only samples that have undergone decalcification

Data transfer frequency
Data transfer frequency	Ad hoc (event based) Unknown

Method of data transfer
Data transfer method(s)	eHealthbox of eHealth Platform

Sites involved in the project

Type of site(s)
Care Provider	General hospitals University hospitals

Health professionals involved (encoding) in the project

Health professionals involved (encoding) in the project
Care Giver	Laboratory Workers Physicians
Specialty of physicians involved (encoding) in the project	Medical oncology
Type of paramedical professionals involved (encoding) in the project	Unknown

Informed consent

Informed consent
Are subjects informed?	Yes
Do subjects have to give their consent?	Yes
How do subjects give their consent?	Yes
Is there a procedure to provide subjects the ability to consult their registered information?	No information available
Is there a procedure to provide subjects the ability to correct their registered information?	No information available
Additional information	No additional information available

Review

Ethics Committee
Authorization by an Ethics Committee?	Yes

Sectoral Committee National Registry (Privacy Commission)
Authorization by the sectorial committee Health / Social affairs of the Privacy Commission	No

Sectoral Committee Health / Social affairs (Privacy Commission)
Authorization by the sectorial committee Health / Social affairs of the Privacy Commission	Yes

Sectoral Committee Crossroads Bank of Enterprises (Privacy Commission)
Authorization by the sectorial committee Crossroads Bank of Enterprises of the Privacy Commission (Y/N)	Not applicable

Data dictionary

Classifications and Terminology
Name	Unknown

Data quality

Data quality
First year for which data is available	No information available
Procedures for checking and validating the source data	No information available
Data compilation process	No information available
Punctuality for the most recent completed data collection: the data collection was completed	No information available
Participation rate of the health institutions	No information available
Participation rate of the health professionals	No information available
Extent of unit non-response	No information available
Extent of the item non-response	The rate of item non-response is not known or unacceptably high (>50%)
Extend to which the collected data are comparable across the Belgian regions	Comparability across the Belgian areas is unknown
Comparable or reconcilable over time	Comparability over time is unknown
Additional information	No additional information available
Extent of problems with the misclassification of statistical units for their key variables	No information available
Can records belonging to same entity be matched?	No information available
Additional information	No additional information available

Data storage

Data storage
The organisation in charge of storage of the collected data, is certified as being compliant with the international standards on information security management system (eg. ISO27001)?	Yes
Additional information	No additional information available

Data access

Data access
Written Data sharing policy?	No information available

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