Biobanking and clinical data registration

Workpackage 2

Objectives

Establish tissue banks of well characterized clinical material in the early months of the project through the EMN net-based communication system.

Access to patients / normal donors and collection of tissue will be ethically implemented to EU regulations, and continuously assessed as directed by the MSCNET Ethics committee.

Description of work

During the first month of the project, each participating centre and each WP-leader will identify a person responsible for biobanking and harmonization of the methods stated above (according to the respective areas of expertise), and a member of each institution is named to be part of the MBB steering committee. The MBB steering committee is headed by the head of WP2. The respective tasks (e.g. protocol for plasma-cell purification, CRF) is worked on by a protocol committee for each task, consisting of a member of the institution heading the workpackage with the main involvement of the task, a member of the MBB, and anyone volunteering from the other participitating groups.

The time frame is set up in a way that MBB material begins to become available early. Protocols and documentation strategies will be published on the MSCNET website and made available to all MSCNET members and, at request, other European institutions and laboratories.

Meetings and consensus conferences (M1 - M9) will be hold to achieve the attributed tasks. These meetings are attached to the regular consortia meetings when possible, or hold separately in the interim time. In detail, the following strategy is planned.
A minimum set of samples and data to be collected by every participating centre will be defined. Due to the high technical requirements of cell enrichment, specialised centres will be identified for this task.
In accordance with EU harmonization on Good Clinical Practice (GCP) future trial case report forms will fulfill the recommendations. An early aim will be to establish a full set of case report forms (CRF) for:

• Newly diagnosed patients with minimal essential data and follow up.
• Active clinical trials.
• Previous trials.
• Biobanking.

Deliverables

• Construction of a common system for biobanks of tissue, cells, selected subsets, RNA, cDNA, DNA, serum, plasma and tissue fluids.
• SOP for extraction and storage of RNA, DNA, and protein fractions as well as generation of cDNA and amplification of RNA prior to application to microarrays.
• SOP for large-scale enrichment of myeloma plasma cells and quality control procedures during and after sample preparation.
• An Internet based database including information on samples collected and clinical data from CRFs.

Milestones

M 2.1 (month 0) The constitutional meeting:

• Consensus on ethical issues/information, consent forms. Set up of an information and informed consent forms for patients / healthy volunteers on the basis of preexisting (UoHe, attached).
• consensus and definition of sampling strategy (samples, timeframe).
• definition of minimum sample set, extended sample set.
• consensus on project, public and institutional samples.
• overview and discussion of different methodological protocols (denoted in I), detailed discussion of responsibilities in extension of the draft / proposal stated above.
• definition of work-group pairs of WP2-group members in accordance to the respective expertise to work on each of the methodological protocols denoted / proposed in I.

M2.2 (month 3) Discussion and consensus on sampling and extraction protocols.

• Planning of data-bank setup. (Organisational issues, data security, pseudonymisation based on GMMG (UoHe)/HOVON (EMC) experience, data exchange).
• Discussion and set up of rules for data exchange exceeding the initial guidelines in place based on UoM experience.
• Laboratory protocols / SOP. For responsibilities pls. see I above; detailed distribution of responsibilities as set up on M1:
• Review / discussion of purification strategies for plasma cell precursors.
• Plasma-cell-purification (MACS, autoMACS, FACS).
• RNA-extraction.
• DNA-extraction.
• Protein -extraction.
• culture of HMCL.
• sample storage.

M2.3 (month 6): Discussion and consensus on major experimental protocols and definition of test strategies (define respective laboratory to test the protocols on quality/practicability).

• Follow up on purification strategies for plasma cell precursors.
• Laboratory protocols / SOP. For responsibilities pls. see I above; detailed distribution of responsibilities as set up on M1:
• Quantitative real-time PCR (e.g. TaqMan).
• GEP (amplification protocol, procedures)
• aCGH
• Follow up on databank-issues.

M2.4 (month 9):

• Follow-up on purification strategies
• Preparation of sample-CRF
• Review of experience with methodological protocols defined on M1, M2, M3
• Finalizing work on database-issues

M2.5 (month 12):

• Follow-up on purification strategies (taking into account the results of UoS and the FACS-workshop).
• Review and refinement of experience with methodological protocols.
• Preparation of biobanking guidelines.
• QC / GLP / GCP issues.

M2.6 (month 18):

• Review and refinement of experience with methodological protocols.
• Review and refinement of CRF.
• Review and refinement of biobanking guidelines.
• Folow up on QC / GLP / GCP issues.

M2.7 (month 24):

• Web based publication of refined and quality controlled methodological protocols.
• Web based publication of sample CRF.
• Continuing quality control of protocols, CRF and interaction.

M2.8 (month 36): Final review as part of this project of

• protocols
• sample CRF
• biobanking
• assessment of continuation of work (e.g. possible clinical applications)

First operational interaction will be available after 3 (protocols), 6 (receiving and sending samples by the central biobank). Protocols and strategies will be continuously worked on during the first phase of the project extensively tested by the project partners and refined during the second and third part of the project. In the later stages of the project, besides the working of the interactions of the biobanks, special emphasis will be laid on performance and control of performance in accordance to GCP/GLP and quality control.