Skin CanceriToBoS BCNNCT05955443
iToBoS Prospective Data Acquisition and Feasibility Study (Barcelona)
An observational study of Skin Cancer, run by The University of Queensland at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- How many people
- 350 participants
- Where
- 1 siteSpain
- Study dates
- 13 Jan 2023to 20 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Over 18
- Able to provide informed consent
Who cannot join
- Unable to stand and hold anatomica pose for 3D total body photography
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic de Barcelona
Barcelona, Catalonia, 08035
Clare Primiero, PhD, +34639222592, c.bover@uq.edu.au
Gisele Rezze, MD, +34677952566, ggrezze@hotmail.com
About this study
Official title: iToBoS Prospective Data Acquisition Study
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.
Read the 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.
- 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.
- 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).
- 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.
- Conditions
- Skin Cancer
- Keywords
- melanoma, skin examination, artificial intelligence, total body photography
- Medical subject headings
- Skin Neoplasms, Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start13 Jan 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion Clinic per a la Recerca Biomédica
- Responsible party
- Principal investigator, Clare Primiero, The University of Queensland
- Investigators
- Josep Malvehy, MD, Principal investigator, Foundation Clinic for Biomedical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955443
- Sponsor's protocol ID
- BARCELONA_ITOBOS
- Other IDs
- 965221
- Acronym
- iToBoS BCN
- Status last verified
- Jun 2024
- First submitted
- 28 Jun 2023
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iToBoS Prospective Data Acquisition Study
- ClinicalTrials.gov ID
- NCT05955443
- Acronym / sponsor ID
- iToBoS BCN / BARCELONA_ITOBOS
- Conditions
- Skin Cancer
- Keywords
- melanoma, skin examination, artificial intelligence, total body photography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- Fundacion Clinic per a la Recerca Biomédica
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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).
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Over 18
- Able to provide informed consent
Key exclusion criteria (1 listed)
- Unable to stand and hold anatomica pose for 3D total body photography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of skin diagnostic categories
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josep Malvehy, MD principal investigator
Foundation Clinic for Biomedical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Cancer, run by The University of Queensland at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clare A Primiero, PhD (+34639222592, c.bover@uq.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of skin diagnostic categories (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.