Registry Next-Generation-Sequencing (NGS) tests for oncology

Molecular detection is currently a part of clinical oncology diagnostics. The recent grow of advanced molecular technologies enables for a certain number of cases to optimize the treatment by incorporating individual, molecular DNA-characteristics of the tumor and of the patient himself: the so-called ‘Targeted Next-Generation-Sequencing (NGS).

The introduction of NGS in molecular oncology diagnostics requires a profound preparatory phase, both in the field and on policy level. A feasibility study, performed by the Cancer center (WIV-ISP) and the KCE, resulted in a roadbook ‘Personalized medicin’ – Introduction of ‘Next-Generation-Sequencing’ in routine oncology and hemato-oncology diagnostics.

This road book contains 10 action points. The current request relates to action point 6: NGS data registration, storage and management.

Data and Resources

Registry Next-Generation-Sequencing (NGS) tests for oncologyjson
Machine-readable representation of this dataset.

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Field	Value
Modified	2019-11-24
Release Date	2018-05-08
Identifier	68f53c1a-6109-4e8b-b7a5-a7f7484f6e8b
License	Creative Commons Attribution
Public Access Level	Public

Protocol

Protocol
Full title of the project	Registry Next-Generation-Sequencing (NGS) tests for oncology
Name or abbreviated title of the project where available	NGS
Source type	Patient registries

Sponsor(s)

Primary organization that oversees implementation of study and is responsible for data analysis.
Name of organisation	Scientific Institute of Public Health [Kankercentrum]

Commissioner(s)

Organisation (1) that commissioned this project
Name of organisation (1)	National Institute for Health and Disability Insurance
Website(s) of organisation (1)	Website

Organisation (2) that commissioned this project
Name of organisation (2)	Federal Public Service Health, Food Chain Safety and Environment - cell quality and patient safety
Website(s) of organisation (2)	Website

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)	Federal Public Service Health, Food Chain Safety and Environment - cell quality and patient safety
Website(s) of organisation (2)	Website

Governance

Governance
Is there a Steering / Accompanying committee?	No information available

General information

General information
Project description	Molecular detection is currently a part of clinical oncology diagnostics. The recent grow of advanced molecular technologies enables for a certain number of cases to optimize the treatment by incorporating individual, molecular DNA-characteristics of the tumor and of the patient himself: the so-called ‘Targeted Next-Generation-Sequencing (NGS). The introduction of NGS in molecular oncology diagnostics requires a profound preparatory phase, both in the field and on policy level. A feasibility study, performed by the Cancer center (WIV-ISP) and the KCE, resulted in a roadbook ‘Personalized medicin’ – Introduction of ‘Next-Generation-Sequencing’ in routine oncology and hemato-oncology diagnostics. This road book contains 10 action points. The current request relates to action point 6: NGS data registration, storage and management.

Therapeutic area
Disease	Cancer

Objective of the project
Main objective of the project	The general aim of the pilot project NGS is to facilitate the stepwise introduction of the NGS technology within the oncological routine for a total period of 5 years. The collection of the NGS data represents an important added value of this new technology for quality guarantee, HTA evaluations, optimal reimbursement and future research, for clinical and public health applications. Specific aims for the data collection via healthdata.be are: The verification of the scope of the performed tests (within the framework as defined by RIZIV, e.g. art. 33bis). The storage of different types of supplied data. In a later phase, a ‘work space’ can be created where all NGS results will be gathered in a molecular registry which will be accessible to resolve research questions.
Additional information	No additional information available

Scope
Scope	Diagnosis

Legal basis

Type of legal basis
Type of legal basis	Unknown

Design of the project

Principal inclusion and exclusion criteria
Principal inclusion criteria	Cancer patients who are entitled to receive molecular profiling by NGS as outlined in the technical parts of the clinical guidelines of the College of Oncology and in line with the recommendations of the “ComPerMed”.

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

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

Sites involved in the project

Type of site(s)
Care Provider	Laboratories: anatomical pathology Laboratories: clinical biology Laboratories: human genetics

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	Pathological anatomy Unknown
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?	Not applicable

Sectoral Committee National Registry (Privacy Commission)
Authorization by the sectorial committee Health / Social affairs of the Privacy Commission	Not applicable

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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