The MENTORING Project starts with a longitudinal observational study of cancer patients, where patients are recruited in the Oncology Departments of two hospitals (Madrid and Parma) and followed up for a period of six months. This study has been called “LISTENING” and can be considered the main task developed during the reporting period. Major milestones accomplished during this period include the drafting of the Project Handbook (month 5), which was uploaded as a Deliverable; the approval of the Listening Protocol by the respective Ethical Committees of Madrid and Parma; and the start of the recruitment process in April (SERMAS, Madrid, Spain) and July (Parma, Italy). By the end of the reporting period, some patients had reached the second (3-month) scheduled visit. The withdrawal rate has remained very low so far.
Regarding the recruitment and follow-up task, a number of activities have been successfully performed, including:
Creation of a Database (LIMS: Laboratory Integrated Management System) to manage information from patients and samples.
Detailed definition of lifestyle data to be collected from patients, including nutritional questionnaires, quality of life (QoL)-related questionnaires, welfare questionnaires, and so on, which were discussed and agreed upon by the two institutions recruiting patients.
Detailed definition of biomarkers to be analysed from patients, including genomic, proteomic, glycomic, glycoproteomic, metabolomic, and metagenomic, as well as biochemical and inflammatory/immunological markers.
Definition of types and numbers of samples to be collected from patients, considering the high number of biomarkers needed for analysis but also respecting the principle of minimal harm to patients.
Design of sample flow between the laboratories where samples are initially collected and processed (SERMAS/IMDEA and University of Parma) and the recipient laboratories (all groups, each specialising in different sets of biomarkers).
Preparation of SOPs (Standard Operating Procedures) to harmonise sample collection and guarantee the highest sample quality throughout the study.
Design of informatics tools to upload, download, and manage comprehensive data coming from very different sources (questionnaires, biochemical analyses, omic studies, clinical data, etc.).
In parallel with the establishment of all infrastructure needed for sample collection, processing, and delivery, two pilot samples were sent to the analytical laboratories to ensure that the system had been correctly designed and to provide some initial data, helping to prevent possible future issues.
In addition, a first version of the Data Management Plan was discussed and prepared, and uploaded as a Deliverable, alongside the Communication and Dissemination Plan, both in month 6 of the project timeline.
