iToBoS Prospective Data Acquisition and Feasibility Study (Barcelona)

Trial Title: iToBoS Prospective Data Acquisition and Feasibility Study (Barcelona)

NCT ID: NCT05955443

Condition: Skin Cancer

Conditions: Official terms:
Skin Neoplasms

Conditions: Keywords:
melanoma
skin examination
artificial intelligence
total body photography

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

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.

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.

Criteria for eligibility:

Study pop:
Patients who are attending the Hospital Clinic de Barcelona for a standard skin examination will be approached to participate in the study. All participants will be adults, aged 18 years or older.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - Over 18 - Able to provide informed consent Exclusion Criteria: - Unable to stand and hold anatomica pose for 3D total body photography

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Hospital Clinic de Barcelona

Address:
City: Barcelona
Zip: 08035
Country: Spain

Status: Recruiting

Contact:
Last name: Clare Primiero, PhD

Phone: +34639222592
Email: c.bover@uq.edu.au

Contact backup:
Last name: Gisele Rezze, MD

Phone: +34677952566
Email: ggrezze@hotmail.com

Investigator:
Last name: Josep Malvehy, MD
Email: Principal Investigator

Start date: January 13, 2023

Completion date: December 20, 2024

Lead sponsor:
Agency: The University of Queensland
Agency class: Other

Collaborator:
Agency: Fundacion Clinic per a la Recerca Biomedica
Agency class: Other

Source: The University of Queensland

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05955443