European Research Initiative on CLL

ERIC | New Project

ERICLL database



Type of Study | European multicenter retrospective and prospective study


Coordinators of the Study

- Carol Moreno | Hematology Department, Hospital Santa Creu I Sant Pau, Barcelona, Spain.

- Anastasia Hadzidimitriou | Institute of Applied Biosciences, Centre for Research and Technology Hellas, Thessaloniki, Greece


Adivisory Committee

- Paolo Ghia | Italy

- Horia Bombea | Romania

- Dena Cohen | UK

- Florence Cymbalista | France

- Michael Doubek | CZ Republic

- Barbara Eichhorst | Germany

- Anastasia Hadzidimitriou | Greece

- Eva Kimby | Sweden

- Vincent Lévy | France

- Christian Maurer | Germany

- Carol Moreno | Spain

- Kostas Stamatopoulos | Greece

Backround and rationale

Despite recent progress, chronic Lymphocytic Leukemia (CLL) remains an incurable disease highlighting the need for large-scale initiatives aimed at addressing the outstanding basic, translational and clinical research questions.

The availability of clinical and biological data of patients with CLL could facilitate CLL such research across Europe, provide accurate information about the state-of-the-art in CLL diagnosis, prognostic assessment and management and also enable the design of clinical trials.

Objectives

Primary

- To collect minimum clinical and biological information of patients with CLL at the time of diagnosis and follow-up. - To develop a data management system and a database for handling and storage of clinicobiological data

Secondary

- To merge with existing databases, adapt to local and project-specific necessities - To obtain information about the impact of CLL in Europe health-systems - To facilitate CLL research across Europe - To extend this minimum dataset according to future research needs and new future projects proposed by members

Design

- Non-interventional study aimed at collecting clinical and biological data of patients with a confirmed diagnosis of CLL according to International Workshop on CLL (IWCLL)-WHO criteria

- Prospective and retrospective data collection

- Data collection and anonymization using a defined user-friendly electronic form, transmitted electronically to ERIC’s server

- Management of observational data will be performed in accordance to applicable standards and data validation procedures to ensure the integrity of the data, e.g. removing errors and inconsistencies in the data.

Development

A. Current status


- Final electronic form set up

- Written protocol finalized (including Informed consent)

- Informed consent as per local rules

- Protocol sent to register at Spanish Regulatory Agency and to EC for approval

B. Testing phase (May 2016 - October 2016) - Retrospective collection

- Greek and Barcelona St Pau data merged

- Merging of data from existing databases in two additional centers (Uppsala, Milano OSR)

C. Pilot phase (November 2016 - June 2017)

-12 centers, which have already participated in ERIC collaborative studies, to send existing database (update)

D. Opening to all ERIC members interested to participate (June 2017 onward)

- Basic information will be required for a center to be able to participate and register its patients thorough either the merging of existing local databases or direct upload of data onto the ERICLL DB

- Regular updates will be asked based on material availability and project-specific necessities

Bibliography

1| Hallek M, Cheson B, Catovsky D et al. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic leukemia updating the National Cancer Institute-Working Group 1996 guidelines. Blood 2008; 111: 5446-5446.

2| Muller-Hermelink HK, Montserrat E, Catovsky D, Campo E, Harris NL, Stein H. Chronic lymphocytic leukemia/ small lymphocytoc lymphoma. In: Swerdlow E et al, eds. WHO classification of tumors of haematopoietic and lymphoid tissue. IARC, Lyon 2008; 180-2.

For further information please contact:

- Anastasia Hadzidimitriou: achatzidimitriou@certh.gr

- Carol Moreno: cmorenoa@santpau.cat

Variables to be collected

A. General information for correspondence (person filling the form)

- ID

- Password

B. Patient identification *

1. Initials

2. Date of birth [dd/mm/yyyy]

3. Date of diagnosis [dd/mm/yyyy]

4. Sex [Male/Female]

5. Type of disease: CLL/ SLL/ MBL

6. Has the patient received treatment? Yes / No

     First line - Start date [dd/mm/yyyy]---- Regimen 
     Subsequent lines - Start date [dd/mm/yyyy]---- Regimen

7. Has the patient already participated in at least one trial? [Yes /No]

Confidentiality protected as by international and local rules

C. Patient and Disease Characteristics

At Diagnosis

1. Rai disease stage

2. Binet disease stage

At first time analysis:

1. Conventional cytogenetics [Yes/ No], If yes:

- Date when it was performed (dd/mm/yyyy)

- Specify: …

2. FISH [del 13q/ del 11q/ trisomy 12/ del 17p, Normal], If yes:

- Date when it was performed (dd/mm/yyyy)

- Specify: …

3. IGHV gene status [Yes/ No], If yes:

- Date when it was performed [dd/mm/yyyy]

- Specify: Unmutated/ Mutated

4. Biological sample stored [Yes/ No], If yes:

- Date when it was performed (dd/mm/yyyy)

- Cryopreserved cells and pellet

- DNA

- cDNA

- Serum

Current status

1. Date of last contact [dd/mm/yyyy]

2. Alive [Yes /No]

3. Date of death [dd/mm/yyyy]

Richter Transformation

1. Richter Transformation [Yes /No]

2. Date of Richter Transformation [dd/mm/yyyy]

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