iToBoS Prospective Data Acquisition and Feasibility Study (Barcelona)

NCT05955443 | Recruiting

• 2 other identifiers: BARCELONA_ITOBOS965221
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Cancer

Keywords

melanoma; skin examination; artificial intelligence; total body photography

Outcome Measures

Primary Outcomes (1)

• Incidence of skin diagnostic categories

  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.

  Through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Over 18
• Able to provide informed consent

You may not qualify if:

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

Sponsors & Collaborators

• The University of Queensland: lead
• Fundacion Clinic per a la Recerca Biomédica: collaborator

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Catalonia, 08035, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Participants will be asked to provide a saliva or blood sample for genetic analysis. Some participants will already have a genetic sample with the hospital. In this case we will ask participant consent to access their biosample.

MeSH Terms

Conditions

Skin Neoplasms; Melanoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas

Study Officials

• Josep Malvehy, MD

  Foundation Clinic for Biomedical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clare A Primiero, PhD

CONTACT

+34639222592; c.bover@uq.edu.au

Josep Malvehy, MD

CONTACT

+34609660505; jmalvehy@clinic.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Investigator

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 21, 2023
• Study Start: January 13, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 20, 2024
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

ES (1)