iToBoS Prospective Data Acquisition and Feasibility Study (Barcelona)

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iToBoS Prospective Data Acquisition and Feasibility Study (Barcelona)

Study Purpose

This study is recruiting patients at their regular skin examination appointments to participate in research. Participation involves having 3D total body photography, completing a 10-15 minute questionnaire, and providing a genetic sample. Normally, the total body photography is part of the patients standard care, as is the collection of a genetic sample. Consenting to this study involves consenting to the use of total body photography images (de-identified), questionnaire answers, and genetic risk information to be used for developing AI algorithms for image analysis of skin lesions, and melanoma-risk profiling for patients.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Over 18.

- Able to provide informed consent.

Exclusion Criteria:

- Unable to stand and hold anatomica pose for 3D total body photography

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05955443
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The University of Queensland
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Josep Malvehy, MD
Principal Investigator Affiliation	Foundation Clinic for Biomedical Research
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Spain
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Skin Cancer

Additional Details

Patients are invited to participate at their regular skin examination visits at Hospital Clinic Barcelona. A member of the research team will read through the Participant Information and Consent Form (PICF) with the patient and answer any questions they may have. Once consent is given, the following study activities will take place. 1. Total Body Photography: this is done with the VECTRA machine that will require you to be photographed in your underwear. The VECTRA is a framework of 92 cameras which will simultaneously capture images of a patient holding one anatomical pose. VECTRA computer software is then used to construct a 3D avatar of the patient, enabling the image record of skin naevi. This imaging is normally part of the patient's skin examination visit. The images used for annotation in research will be de-identified (anonynmised) by firstly removing any images of the face and other identifying features (e.g. tattoos, scars, nipples), then processing the 3D avatar into small 2D images of 5x8cm section of skin. These methods are designed to protect patient privacy of images used for AI development. 2. Complete a Questionnaire: consists of 45 items/questions, taking approximately 10 minutes to complete. Questionnaire data is designed to collect information relevant to melanoma risk, while maintaining a low risk of being individually identifiable. topics cover include demographics, skin cancer history, sun/health behaviour, and phenotype information (e.g. hair/skin/eye colour). 3. Genetic sample: in some cases the hospital will already hold a genetic sample, in this case we ask patient consent to access this information. When no sample is on record, we will ask the patient to provide a saliva or blood sample for genetic analysis. Genetic information will be analysed by looking for single nucleotide polymorphisms (SNPs) relating to melanoma risk (approximately 80-100 SNPs to be analysed). A polygenic risk score (PRS) is then calculated based on the presence or absence of relevant SNPs. The final PRS will be used in the study (no individual genetic information will be shared outside the hospital. All de-identified data (image, survey, and PRS) are then used by the iToBoS consortium to develop a cognitive assistant (AI model) to provide clinician support in screening for melanoma using total body photography.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.