Registries

Hematology Registry

The Belgian Cancer Registry (www.kankerregister.org) has established a database of all cancer patients diagnosed in Belgium. However, the registration of hematological malignancies is not optimized:

1. The classification of hematological malignancies is largely obsolete and thus the epidemiology of hematological malignancies cannot be established
2. Many standardly recorded parameters are not appropriate for hematological malignancies and important information is missing.

The BHS has thus embarked on a collaboration with the Belgian Cancer Registry to :

1. Re-define the classification of hematological malignancies within the Belgian Cancer Registry database, from which to study the epidemiology of hematological malignancies in Belgium;
2. Add hematology-specific data to the database and implement them in the different hospitals. Among other things, the registry should thus facilitate the Identification of rare malignancies for translationnal research.

Hematology registry coordinator : A Sonet (anne.Sonet@sang.ucl.ac.be).

Transplant Registry

Again in collaboration with the Belgian Cancer Registry (www.kankerregister.org), and with the support of the Belgian Foundation against Cancer (www.cancer.be), the BHS is preparing the establishment of a Belgian Transplant Registry of all hematopoietic cell transplants performed in Belgium.

Transplant registry coordinator : J Maertens (Johan.Maertens@uz.kuleuven.ac.be).

Background

• Hematopoietic cell transplantation (HCT) is the therapy of choice for selected patients with a number of severe hematological disorders.
• Approximately 700 HCT are performed each year in Belgium.
• There are 9 hospitals with Federal approval for both allogeneic and autologous HCT and 7 additional hospitals with Federal approval for autologous HCT only.
• The INAMI/RIZIV implemented in 2006 a new nomenclature for HCT. Two conditions for reimbursement are: (1) center participation in a peer review process; (2) EBMT accreditation.
• All centers agreed to participate in such a peer review process of HCT activity in Belgium. However, this has not been implemented so far for lack of funding.
• EBMT accreditation (a very easy procedure) has been stopped at the end of 2010 and will soon be replaced by JACIE accreditation (a very thorough process).The JACIE European accreditation program of HCT activities could become mandatory within a short period of time, both at the European level and at the Belgian level.
• All approved Belgian HCT centers participate into the EBMT PROMISE database.
• HCT is the subject of intensive clinical research internationally. This research needs to be intensified in Belgium.
• Relevant clinical data on HCT procedures and outcomes in Belgium are collected and registered many fold from the same patients. This is a waste of time and resources.

Objectives

• The objective of the project is to set up a fully operational Belgian registry of HCT.
• The Registry would collect minimal essential data on all HCT activity performed in Belgium and constitute a unique, centralized, multipurpose database of HCT data in Belgium. The database would be fully integrated with the database of the Belgian Cancer registry.
• This database would thus serve the objectives of :
  • The Belgian Cancer Registry;
  • Quality improvement programs : INAMI/RIZIV peer review & MDPB quality evaluation;
  • Scientific clinical research programs : retrospective clinical studies & prospective clinical trials run by the BHS Transplant Committee;
  • International collaboration, in particular with the EBMT.

Partners

• Belgian Cancer Registry (BCR).
• Belgian Foundation against Cancer.
• Belgian Haematological Society (BHS).
• Transplant Committee of the BHS (BHS-TC.
• Marrow Donor Program-Belgium (MDPB) scientific committee.
• Belgian Transplant Centers (TC).
• European Blood and Marrow Transplant group (EBMT).
• The French “Agence de Biomédecine”, a French national agency involved in the regulation and evaluation of transplant activities in France.
• The French “Société Française de Greffe de Moelle et de Thérapie Cellulaire” (SFGM-TC), which has developed a similar national registry of HCT in collaboration with the EBMT.

Methods

• A grant has been provided by the Belgian Foundation against Cancer (www.cancer.be) to establish the Registry over 2 years.
• The BTR will be created and managed by the Belgian Cancer Registry, with the scientific collaboration of the Belgian Haematological Society . The data will be co-owned by the BCR and the BHS.
• Data collection:
  • Data (MED A and MED B) will be entered by each center into the EBMT database Promise, through electronic or paper transmission of data;
  • The EBMT will do all the job of data validation (data verification, queries to centers, data correction);
  • The EBMT will regularly extract all data from Belgian centers and send them to the Belgian HCT registry. In a first phase, only MED-A data will be extracted. In a later phase, also MED-B data will be extracted.
• The initial steps for data collection and analysis will involve: 
  • Definition of the format and content of the database;
  • Establishment of reciprocal electronic data transmission between the EBMT PROMISE database ant the BTR database;
  • Implementation of a flexible data extraction process;
  • Software implementation, in particular the French “Agence de biomedicine” software for comparative HCT outcome analysis;
  • Preparation of standardized data extraction and data analysis plans for the different types of statistical analyses (annual report, peer review, prospective and retrospective studies);
• A steering committee of 10 members will assume the scientific supervision of the BTR.
  • The medical director of the Belgian Cancer Registry;
  • The president of the BHS, chair of the BHS transplant committee and president of the MDP-B asbl/vzv; 
  • Representatives of academic and non-academic TC.
• The methodology for peer review and scientific studies will be established.

Deliverables 

• Global and individualized (in each center) quality evaluation of patient outcome (software from French “Agence de Biomédecine”);
• Peer review (INAMI/RIZIV transplant nomenclature);
• MDPB quality evaluation;
• Retrospective clinical studies;
• Data collection for prospective clinical studies of transplant committee.