ERIC aims to promote and/or advance the determination of IGHV gene mutational status in CLL for diagnostic and prognostication purposes by educating the hematological community about the need to apply standardized and consistent methods based on the state-of-the-art in immunology and the most innovative bioinformatics tools.
This will ensure reliable and comparable results among different institutions in Europe, and elsewhere, ultimately improving patient care while fostering interaction with clinical study groups and the pharmaceutical industry.
Working Plan and Specific Objectives
The project will accomplish its goals using the following approaches:
6TH EDUCATIONAL WORKSHOP ON IMMUNOGLOBULIN GENE SEQUENCE ANALYSIS IN CLL
This Workshop was held in Uppsala, Sweden from 22-23 September 2016. It comprised a mixture of lectures and applied sessions held by 14 experts in the field on immunoglobulin gene analysis and interpretation in CLL. Over 80 international scientists assisted this event. Participants were introduced to the scientific rationale for performing the diagnostic procedures and the basic principles of the relevant methodologies, being exposed to the actual practical work from the sample collection to the drafting of the final clinical report. This activity can also be extended to clinical study groups and industry partners to improve both the standardization of the assay and the interpretation of the results within investigator – or company-driven clinical trials. More information and the presentations that were given on this workshop can be found in the Past Eric Meetings section.
EDUCATIONAL WORKSHOP ON NGS IMMUNOGENETIC ANALYSIS IN CLL
ERIC plans to host a 2-day workshop for 60 participants at the end of 2017 (time and place not yet confirmed) with the emphasis on the provision of the knowledge and skills necessary to analyse, interpret and report NGS IG gene sequence results in CLL for (i) the assessment of SHM status; and (ii) the detection of MRD. The aim is to continue to lay the groundwork for defining quality standards that will improve accuracy and ensure consistency and reproducibility throughout the international community. This will assist in bridging the ´generation gap´ from low-throughout to NGS immunogenetic analysis and, thus, offer solutions to currently unmet needs in different clinical applications related to the prognostication and response assessment in CLL.
ESTABLISHMENT AND EXPANSION OF THE IG NETWORK
To further intensify and advance activities related to immunogenetic analysis in CLL, in 2015 ERIC launched an IG Network with the aim to educate the hematological community about the need to apply standardized and consistent methods based on the state-of-the-art in immunology and the most innovative bioinformatics tools.
This network currently consists of 2 certifying centres (France and Greece) and 7 reference centres (Czech Republic, France, Germany, Greece, Italy, Sweden and Nordic countries and The Netherlands).
This Network will expand through (i) including all ERIC-certified labs, (ii) regional dissemination events in different countries held by the IG network member labs where the need for IG analysis and certification will be stressed and current practices will be presented. (iii) planned outreach activities in the US and the Middle East.
CERTIFICATION OF IMMUNOGLOBULIN GENE SEQUENCE ANALYSIS IN CLL
This initiative aims at designing a procedure for Quality Assessment in Laboratory Diagnostics of CLL to ensure that laboratory results regarding Immunoglobulin Gene sequence analysis and, in particular, determination of IGHV gene mutational status, are reliable and comparable among different laboratories in Europe, and elsewhere, in order to facilitate optimal patient care. It is addressed to those who recently introduced novel diagnostics and need reassurance about the quality of results, all laboratories performing diagnostics for patients with CLL and also those who need official certification of quality control for applied methodologies (hospital management, insurance companies, and pharmaceutical companies).
This initiative will be supervised by the IgCLL Group (www.igcll.org), a working group within ERIC, and will be articulated in three phases, as follows:
PHASE 1: COMPLETION OF PARTICIPATION FORM
Interested laboratories should complete the participation form in order to be eligible for the next certification round. The participation form can be found by clicking here
PHASE 2: LABORATORY AND BIOINFORMATICS ANALYSIS
Once the list of participating laboratories has been defined, these laboratories will be asked to confirm their shipping details and confirm that they still wish to participate.
The certifying centre will prepare the quality control material – genomic DNA from 5 CLL cases of diverse IGHV gene mutational status – and ship this to the corresponding laboratories.
Laboratories will be informed as to when they should receive their samples and will be provided with instructions (via email) as to how to proceed with the certification process. The laboratories will be provided with the samples and all the necessary guidelines in order to carry out the analysis. The analysis will be completed through the submission of an online personalized form which must be sent within 3 months.
PHASE 3: EVALUATION & DECISION
The results will be assessed by the IgCLL group in terms of both the analysis per se (e.g. examination of sequencing runs) and IG sequence interpretation. Successful laboratories will be provided with a certificate (Standard) and a letter summarizing their performance and unsuccessful laboratories will be asked to reapply at the next round and be provided with necessary guidance.
SUMMARY: CERTIFICATION ROUNDS
The first round of IG Certification was completed on 30 November 2016 and the second round of IG Certification is currently ongoing. The participation form remains active for the whole year for those labs interested to participate in the next round. Should your lab be interested, then please ensure that you complete and send the participation from which can be found here
ONLINE WEB TOOLS
The following online web tools have been created and are available in order to provide laboratories with guidance and assistance to achieve reliable and comparable results for IGHV Gene Analysis Certification.
ONLINE HELP DESK
An online discussion forum is already available for support and troubleshooting for interpretation of IGHV-IGHD-IGHJ gene rearrangement sequences by a review board of experts. This forum has been active since January 2007 and has so far received >400 queries from different Institutions in Europe and the US.
GUIDANCE TOOLS FOR CERTIFICATION
IG CERTIFICATION REQUIREMENTS
A brief checklist summarizing what is needed to be successful in the certification round.
IG REPORT EXAMPLES FILE
This template serves as an example in the correct and comprehensive result report that should be provided to the physicians.
TECHNICAL AND REPORT GUIDELINES
These guidelines should be used for labs for the experimental analysis of your samples and reporting of the lab results