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iToBoS BCN: iToBoS Prospective Data Acquisition Study (Barcelona)

Sponsor
The University of Queensland (Other)
Overall Status
Recruiting
CT.gov ID
NCT05955443
Collaborator
Fundacion Clinic per a la Recerca Biomedica (Other)
255
Enrollment
1
Location
11.2
Anticipated Duration (Months)
22.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    255 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    iToBoS Prospective Data Acquisition Study
    Actual Study Start Date :
    Jan 13, 2023
    Anticipated Primary Completion Date :
    Sep 30, 2023
    Anticipated Study Completion Date :
    Dec 20, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of skin diagnostic categories [Through study completion, an average of 1 year]

      Images will be used to label different skin diagnostic categories. These labelled images are then used as a training dataset for machine learning in developing algorithms for skin lesion diagnosis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Over 18

    • Able to provide informed consent

    Exclusion Criteria:
    • Unable to stand and hold anatomica pose for 3D total body photography

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Clinic de Barcelona Barcelona Catalonia Spain 08035

    Sponsors and Collaborators

    • The University of Queensland
    • Fundacion Clinic per a la Recerca Biomedica

    Investigators

    • Principal Investigator: Josep Malvehy, MD, Foundation Clinic for Biomedical Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Clare Primiero, Associate Investigator, The University of Queensland
    ClinicalTrials.gov Identifier:
    NCT05955443
    Other Study ID Numbers:
    • BARCELONA_ITOBOS
    • 965221
    First Posted:
    Jul 21, 2023
    Last Update Posted:
    Jul 21, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Clare Primiero, Associate Investigator, The University of Queensland
    melanoma
    skin examination
    artificial intelligence
    total body photography
    Additional relevant MeSH terms:
    Skin Neoplasms

    Study Results

    No Results Posted as of Jul 21, 2023