CERTIFIED CENTERS+
  • ARGENTINA
  • AUSTRALIA
  • AUSTRIA
  • BELGIUM
  • BRAZIL
  • BULGARIA
  • CANADA
  • CHINA
  • CROATIA
  • CYPRUS
  • CZECH REPUBLIC
  • DENMARK
  • ESTONIA
  • FINLAND
  • FRANCE
  • GERMANY
  • GREECE
  • HONG KONG
  • HUNGARY
  • IRELAND
  • ISRAEL
  • ITALY
  • JORDAN
  • LITHUANIA
  • MACEDONIA
  • NETHERLANDS
  • NORWAY
  • POLAND
  • PORTUGAL
  • RUSSIA
  • SLOVAKIA
  • SLOVENIA
  • SOUTH AFRICA
  • SPAIN
  • SWEDEN
  • SWITZERLAND
  • TAIWAN
  • TURKEY
  • UNITED KINGDOM
  • UNITED STATES
BACKGROUND+

The clonotypic B cell receptor immunoglobulin (BcR IG) is critically implicated in the pathogenesis of chronic lymphocytic leukemia (CLL). This is supported by the subdivision of patients with CLL in two categories with markedly different clinical behavior and outcome based on the load of somatic hypermutations (SHM) across the sequence of immunoglobulin heavy variable (IGHV) gene of the clonotypic BcR IG. In specific, patients with no or few SHMs within their IGHV genes (germline identity against the closest germline gene ≥ 98%; “unmutated” CLL, U-CLL) experience a significantly more aggressive disease than those with a significant SHM load (germline identity < 98%; “mutated” CLL, M- CLL). Besides these two main categories, there is also “borderline-mutated” CLL (germline identity of 97- 97.99%), which concerns a mixed group of cases with indolent and aggressive disease, underscoring the need of close follow-up of these patients.

IGHV gene mutational status is one of the most robust prognostic markers in CLL, readily identifiable at diagnosis and independent of clinical stage or other biomarkers. More importantly, it remains stable over time and has a strong predictive value for response to treatment. The important role of robust immunogenetic characterization in the proper management of patients with CLL is reflected in the most recent guidelines of the International Workshop on CLL (iwCLL) indicating that this biomarker should be assessed prior to treatment in all patients with CLL, i.e., in both general practice and clinical trials. CLL is notable for the existence of BcR IG stereotypy that defines subsets of patients with shared immunogenetic features and consistent clinicobiological profiles. From a clinical perspective, the most notable examples are stereotyped subsets #2 and #8. Subset #2 is associated with aggressive disease regardless of the SHM status: information regarding subset #2 membership is already used for stratifying patients in clinical trials (e.g. UK CLL FLAIR study). Subset #8 displays the highest risk for Richter’s transformation amongst all CLL, prompting specific recommendations regarding clinical management.

Given the obvious importance of BcR IG analysis for clinical decision making in CLL, ERIC, the European Research Initiative on CLL, has taken several initiatives for promoting good practices (Agathangelidis et al. Jove 2018) and providing standardized guidelines to the international scientific community (Agathangelidis et al. Leukemia 2022).

AIMS+

ERIC aims to promote and/or advance the analysis of the clonotypic BcR IG, including the determination of IGHV gene mutational status and the assessment to major stereotyped subsets #2 and #8 for diagnostic and prognostication purposes by educating the hematological community about:

  1. the need for performing immunogenetic analysis of the BcR IG in all CLL cases
  2. the quality of the appropriate experimental and analytical techniques to be utilized by diagnostic laboratories to ensure reliable and comparable results across different institutions in Europe and abroad.

Ultimately, this will improve optimal patient care and will increase the availability of relevant tests, allowing clinical study groups, as well as the pharmaceutical industry, to properly identify particularly difficult-to-treat CLL patients in routine diagnostics and clinical trials with the aim to further improving long-term outcomes.

The ERIC IG Network aims to be relevant to all personnel working in laboratories performing diagnostics for patients with CLL, including those who have never performed these analyses in the past, those who have recently introduced novel diagnostics and need reassurance on the accuracy of the procedure, and those already experienced in their use who want to keep high quality of applied methodologies. It also aims to increase physicians’ awareness of the need to test all CLL patients requiring therapy in order to select the most appropriate treatment for each case.

WORKING PLAN AND SPECIFIC OBJECTIVES
The ERIC IG Network accomplishes its goals using the following approaches:

The online help desk has been specifically set up for laboratories facing any difficulties during the analysis. It provides methodological as well as interpretation consultation.

  • IG GENE ANALYSIS TEMPLATE REPORT FORM

This template serves as an example of the correct and comprehensive result report that should be provided to the physicians.

  • A MANUAL FOR IG GENE ANALYSIS

This manual contains concise information on the IG GENE analysis process from sampling to data interpretation.

STRUCTURE+
REFERENCE CENTRES
  • CZECHIA
  • FRANCE
  • GERMANY
  • GREECE
  • ITALY
  • SWEDEN AND NORDIC COUNTRIES
  • THE NETHERLANDS
CERTIFYING CENTER
  • GREECE
PARTICIPATION FORM+
IG Network PARTICIPATION FORM
Full Name:
Institution: (Name that will appear on the diploma
Department:
Address to send the samples:
City:
Postal code:
Country:
E-mail:
Additional e-mail:
Phone:
Additional phone:
If your country doesn’t belong to the European Union, it is compulsory to provide the VAT/TAX number of your laboratory (HST, Federal Tax Number, ID…)
Tax number:
IG Network PARTICIPATION FORM
Full Name:
Institution: (Name that will appear on the diploma
Department:
Address to send the samples:
City:
Postal code:
Country:
E-mail:
Additional e-mail:
Phone:
Additional phone:
If your country doesn’t belong to the European Union, it is compulsory to provide the VAT/TAX number of your laboratory (HST, Federal Tax Number, ID…)
Tax number:
HELP DESK+
IG Network HELP DESK
Please remember to attach the sequence at the end of the form.
Sequences from both forward and reverse strand should be included.
Full Name:
Institution / Clinic:
City:
Postal code:
Country:
Case ID:
E-mail:
Phone:
Molecule type:
Method used:
If other method, please specify:
Enter your question:
I agree to have my case included in the ERIC database of problematic cases
Please upload your file(s) here (limit of 5 documents). Please attach the sequence in any of the supported formats.
Department:
Institution Address:
City:
Postal code:
Country:
E-mail:
Phone:
I agree to have my case included in the ERIC database of problematic cases
IG Network HELP DESK
Please remember to attach the sequence at the end of the form.
Sequences from both forward and reverse strand should be included.
Full Name:
Institution / Clinic:
City:
Postal code:
Country:
Case ID:
E-mail:
Phone:
Molecule type:
Method used:
If other method, please specify:
Enter your question:
I agree to have my case included in the ERIC database of problematic cases
Please upload your file(s) here (limit of 5 documents). Please attach the sequence in any of the supported formats.
Department:
Institution Address:
City:
Postal code:
Country:
E-mail:
Phone:
I agree to have my case included in the ERIC database of problematic cases
FAQ+

How long does the lab have to analyse the samples?
Normally two months. Deadlines will be outlined.

How long for results to be sent after submitting the results?
Deadline will be provided.

How should the results be submitted?
Via an online personalised form that you will be sent.

Who should I contact if I need assistance?
Please email the ERIC Office.

How long is the certification valid for?
Three years.

How can I renew my certification?
Renewals are made by GenQA and UK NEQAS LI. You can find all the information here.

How can I certify my lab?
Please complete the Participation Form

How long does it take to receive participation confirmation?
You will be contacted via email. This may take a few weeks.

Who decides whether my lab can participate?
The certifying centre in charge of the Round.

What happens if there are no more spaces available?
Your lab will be included in the next available Round.

Is Certification free?
Yes it is. All courier costs are covered by ERIC.

How many certification rounds are there per year and when will the next one be?
Normally 2 per year: one gDNA-based and one RNA/cDNA-based.

 

How long is the certification valid for?
Three years.

How can I renew my certification?
Renewals are made by GenQA and UK NEQAS LI. You can find all the information here.

How can I request a duplicate certificate?
Please contact the ERIC Office at office@ericll.org

Which type of certification exists?
Standard.

How many times can my lab reapply if unsuccessful?
There is no limit.

How can I find out more about certified labs?
Please click on the Certified centres and Certification Round sections on the website.

 

When will the samples be sent?
You will be informed via email.

How many samples will be sent?
You will receive five samples.

Which type of nucleic acid will be tested?
There is one round for DNA and another one for RNA/cDNA per year.

Can my lab test both DNA and RNA?
Yes, but for your lab to receive certification, both of these methods must pass.

How long does the lab have to analyse the samples?
Normally two months. Deadlines will be outlined.

How long for results to be sent after submitting the results?
Deadline will be provided.

How should the results be submitted?
Via an online personalised form that you will be sent.

Who should I contact if I need assistance?
Please email the ERIC Office.

How long is the certification valid for?
Three years.

How can I renew my certification?
Renewals are made by GenQA and UK NEQAS LI. You can find all the information here.

How can I certify my lab?
Please complete the Participation Form

How long does it take to receive participation confirmation?
You will be contacted via email. This may take a few weeks.

Who decides whether my lab can participate?
The certifying centre in charge of the Round.

What happens if there are no more spaces available?
Your lab will be included in the next available Round.

Is Certification free?
Yes it is. All courier costs are covered by ERIC.

How many certification rounds are there per year and when will the next one be?
Normally 2 per year: one gDNA-based and one RNA/cDNA-based.

 

How long is the certification valid for?
Three years.

How can I renew my certification?
Renewals are made by GenQA and UK NEQAS LI. You can find all the information here.

How can I request a duplicate certificate?
Please contact the ERIC Office at office@ericll.org

Which type of certification exists?
Standard.

How many times can my lab reapply if unsuccessful?
There is no limit.

How can I find out more about certified labs?
Please click on the Certified centres and Certification Round sections on the website.

 

When will the samples be sent?
You will be informed via email.

How many samples will be sent?
You will receive five samples.

Which type of nucleic acid will be tested?
There is one round for DNA and another one for RNA/cDNA per year.

Can my lab test both DNA and RNA?
Yes, but for your lab to receive certification, both of these methods must pass.