Combination of clinical information, genetics and imaging in the first clinical study

The iToBoS international project includes a novel total body scanner and a Computer Aided Diagnostics (CAD) tool, to integrate various data sources such as medical records, genomics data and imaging data. The first clinical study was created while iToBoS scanner is being manufactured.

The idea is to create a flow of events that culminates with the development of the CAD tools. Firstly, the participants will be recruited during their visit to the Department of Dermatology of the Hospital Clinic of Barcelona through their routine appointment for skin examination. A brief description of the new research, participant information and consent forms will be provided to the patients. In the participant information form the study objectives are explained and how the data/images privacy are protected. The participants will be asked to consent to VECTRA images to be used, to complete the study questionnaire and to consent the genetic analysis.

Once the individual has consented to participate in this research study, they will complete the online questionnaire with four categories of information: demographics (age, year of birth, sex, country of birth, current country of residence, previous country of residence, height, weight, marital status, educational level, occupational status and ancestry); Skin Cancer History (information of personal melanoma and other skin cancers and familial history of melanoma); Sun/health behaviour (sun exposure, sunbed use, immunosuppressants, smoking status); and phenotype information (hair, eye and skin colour, skin phototype, freckle and nevi count).

For the DNA analysis, the participant will be asked to collect a saliva sample and this information will be used to develop a melanoma risk score.

Finally, the images will be taken with VECTRA scanner, and they will be de-identify as a security measure.

All collection, processing, storing of study data will be saved on the FCRB secured server, password protected. Once The datasets are ready to share, they will be uploaded onto a secured cloud server managed by iToBoS research partner SZTAKI, with security measures in place to protect data privacy. Use of data by iToBoS research partners will be outlined in a Data Sharing Agreement.