Deliverables

This deliverable has been conceived in the frame of T4.3 “General population screening”, T4.4 “Diagnosis and precision follow-up and stratification” and T4.5 “Contextual-empirical investigations to evaluate the realization of identified values”. These tasks are devoted to the recruitment of a prospective cohort of around 3,000 volunteers that will be followed up for 2 years and on the diagnosis, including Indeterminate Pulmonary Nodules (IPN) characterization, with an accentuation on the Never Smokers and Reduced Smokers (NSRS) patients, incorporating Breath Analyser (BAN), Wide-biomarker-spectrum Multi-Use Sensing Patch (WBSP) and spectrometry-on-card (SPOC) into clinical studies.

Regarding Task 4.5, it examines whether identified socio-technical values (in WP1-3) (e.g., transparency, bias, accountability, explanability) are realized when the technology is used. To achieve this goal, the different contexts of the use of technology are to be analysed as different contextual variables come into play to impact the way values are understood.

Volunteers have been recruited from different clinical centers (“Servicio Andaluz de Salud” (SAS) and “Osakidetza Servicio Vasco de Salud” (OSA), in Spain; “Centre Hospitalier Universitaire de Liège” (CHUL) in Belgium, and “Centre for Tuberculosis and Lung Diseases (CTLD) of Riga East University Hospital (REUH)” in Latvia). Non-invasive devices such as Breath Analyzer (BAN), Multiomics (MO) and spectrometry-on-card (SPOC) are monitoring these participants.

The entire study cohort is currently being followed up. For 2 years, participants of the study will attend to 4 visits: baseline, month 6, month 12 and month 24. During these visits, the following tests and procedures will be carried out:

– Baseline visit: blood test, spirometry, lifestyle questionnaires, sociodemographic data, medical record data, exposure to harmful agents data, physical exploration, LDCT scan and new lung cancer screening devices testing (breath analyzer and spectrometry-on-card)
– 6 months visit: remote visit where sociodemographic data, medical record data and exposure to harmful agents data will be recorded.
– 12 months visit: spirometry, lifestyle questionnaires, sociodemographic data, medical record data, exposure to harmful agents’ data and physical exploration.
– 24 months visit: spirometry, ifestyle questionnaires, sociodemographic data, medical record data, exposure to harmful agents’ data, physical exploration, low-dose computed tomography (LDCT) scan and new lung cancer screening devices testing (breath analyzer and spectrometry-on-card).

(See the following of the Executive Summary in file).

This deliverable has been conceived in the frame of T4.2 “Clinical protocols and requirements”, which is devolted to the organization of the assessment methodology that will be implemented during the development of each use-case at different levels after risk stratification of citizens and clinical scenario. All the designs will be based on the feedback and results after of tasks developed in WP3 and WP5. The following actions will be deployed:

– developing and agreeing on the sampling plan;
– choosing and testing measurement instruments;
– choosing the early diagnosis clinical pathways;
– choosing the diagnosis workflow; and
– planning the data collection and the validation protocols.

After the protocol design (which has already been finalized), all the authorizations required by the regulatory authorities will be obtained.

This deliverable provides the essential regulatory and research documents for the beginning and development of Task 4.3: “General population screening” under which the prospective clinical study will start recruiting participants and gathering data for the LUCIA project.

The content of this deliverable summarizes the clinical protocol for the cohort study in the general population screening and the regulatory authorizations that must be obtained before the enrollment of the first participant in the study.

This deliverable includes the following information:

– Final version of the study protocols of each clinical site as sent to each one of their respective ethics committees.
– Regulatory authorizations required for the enrolment of the first study participant.

The consortium partners have finalized and agreed on the common prospective clinical protocol, which ensures we reach the highest standards of quality and clinical and scientific relevance. The protocols have already been submitted to each one of the Ethics Committees for its approval request in December 2023.

We foresee to obtain the approval of the Ethics Committees in the coming months and start the recruitment of the volunteers that will participate in the prospective clinical study as soon as we get those approvals.

Since the approval has not been obtained yet, we provide in this document the documents of Request for Evaluation of research projects by the Ethics Committees of each clinical site until we obtain the approvals. Once we get them, we will provide also these regulatory authorizations.

This deliverable has been conceived in the frame of T4.2 “Clinical protocols and requirements”, which is devolted to the organization of the assessment methodology that will be implemented during the development of each use-case at different levels after risk stratification of citizens and clinical scenario. All the designs will be based on the feedback and results after of tasks developed in WP3 and WP5. The following actions will be deployed:

– developing and agreeing on the sampling plan;
– choosing and testing measurement instruments;
– choosing the early diagnosis clinical pathways;
– choosing the diagnosis workflow; and
– planning the data collection and the validation protocols.

After the protocol design (which has already been finalized), all the authorizations required by the regulatory authorities will be obtained.

This deliverable provides the essential regulatory and research documents for the beginning and development of Task 4.3: “General population screening” under which the prospective clinical study will start recruiting participants and gathering data for the LUCIA project.

The content of this deliverable summarizes the clinical protocol for the cohort study in the general population screening and the regulatory authorizations that must be obtained before the enrollment of the first participant in the study.

This deliverable includes the following information:

– Final version of the study protocols of each clinical site as sent to each one of their respective ethics committees.
– Regulatory authorizations required for the enrolment of the first study participant.

The consortium partners have finalized and agreed on the common prospective clinical protocol, which ensures we reach the highest standards of quality and clinical and scientific relevance. The protocols have already been submitted to each one of the Ethics Committees for its approval request in December 2023.

We foresee to obtain the approval of the Ethics Committees in the coming months and start the recruitment of the volunteers that will participate in the prospective clinical study as soon as we get those approvals.

Since the approval has not been obtained yet, we provide in this document the documents of Request for Evaluation of research projects by the Ethics Committees of each clinical site until we obtain the approvals. Once we get them, we will provide also these regulatory authorizations.