Work Package 1
Lead Beneficiary NKUA
Annotation of available samples and datasets. Collection of new samples
1. Create a comprehensive database of samples and associated data relevant for onset of active MM from MGUS/sMM
2. Collect new samples with complementary/missing features to the ones existing in biobanks
Task 1.1: Record and annotate the available clinical samples and associated data (demographic, clinical, omics, lifestyle, exposure, environmental, etc.) (NKUA, BRFAA, UKW, UNITO, UNAV, CNRS, ATOS M1-12).
The clinical partners of the consortium have previously established actively operating dedicated clinics for individuals “at risk” with MGUS, with early disease (sMM), and MM. Enrolled subjects meet prespecified inclusion criteria presented in detail at the methodology section of the proposal (Tables 1 and 2). These patient cohorts are followed-up prospectively at regular intervals (every 4–12 months) according to a defined protocol in order to monitor longitudinal changes in multiple clinical and molecular features (Figure 2). Clinical assessment of the MGUS, sMM, and MM groups is accompanied by the collection of biological specimens (blood, urine, bone marrow biopsies, etc.) at baseline (i.e., inclusion visit) and at the time of disease onset (in cases of transition from pre-disease to classified/clinical disease). The consortium has already collected biological samples from a large number of individuals with MGUS (n >2500), sMM (n >2200), MM (n >2000), as well as from several thousands of healthy individuals, which will be used as a reference. In addition, a variety of relevant environmental and lifestyle exposures are tracked including tobacco and alcohol use, serum vitamin levels, physical activity, sun exposure and use of sun protection measures, and diett. For individuals at the preclinical state, transition to MM is ascertained by the fulfillment of the respective validated classification criteria (Table 1). The use of treatments is also documented. The relevant information will be evaluated and organized in collaboration with partners in charge of data integration (CING, ATOS) so that it can be processed according to the tasks described in WP4. Associated deliverables: D1.1
Task 1.2: Sample collection by clinical centers to expand the bio-repository and enable future validation studies of molecular/clinical features and environmental factors contributing to MM development (NKUA, UKW, UNITO, UNAVARRA, CNRS, M1-48).
In order to increase the number of available biological samples and set the stage for future studies on the discovered molecular, clinical and environmental features for health-to-disease transition in MM, we will collect samples and information throughout the 48-month duration of the project. The inclusion criteria and clinical monitoring protocol will be as specified in Tables 1 and 2, and Figure 2 for the ongoing MGUS, sMM, MM cohorts. Thus, we will recruit additional ‘at-risk’ individuals and identify new subjects who progress into MM. Based on the capacities of the collaborating clinical centers it is expected that biological sample and information will be collected from more than 6000 individuals/patients. Associated deliverables: D1.2