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NCT05075356: iToBoS

iToBoS: Clinical Data Acquisition Study

Status unknown NA Last updated 14 May 2024
What this trial tests

NA trial testing The intelligent total body scanner (iToBoS) in Melanoma in 600 participants. Status unknown.

Timeline
1 September 2024
Primary endpoint
30 March 2025
30 March 2025

Quick facts

Lead sponsorThe University of Queensland
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment600
Start date1 September 2024
Primary completion30 March 2025
Estimated completion30 March 2025

Drugs / interventions tested

Conditions studied

Sponsor

The University of Queensland

Who can join

18 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The (overarching) iToBoS Project involves 18 research partners spanning the European Union (including UK and Israel), and 1 Australian partner. The overall aim is to develop an AI assisted diagnostic platform for the early detection of melanoma. The Clinical Data Acquisition Study (this study) will recruit 600 participants across 3 international sites (Brisbane, Italy, and Spain). The primary objective is to compare the quality and resolution of conventional dermoscopic images of skin lesions with the full-body images captured by the iToBoS imaging system. Secondary objectives are to collect imaging, clinical and genetic data across the three sites, to create labelled datasets for use in training the iToBoS AI component. Also, to refine and develop a holistic melanoma risk score method to be used for the iToBoS system. Lastly, to assess safety of the iToBoS system. At study site we will aim to recruit 200 participants stratified by risk (of melanoma) categories (low/normal, high, and ultra-high). Participants will be required to attend 3 study visits (months 0, 6 and 12), for total body imaging with the iToBoS system, and dermoscopic images of individual moles. Genetic research and clinical testing are an optional part of the study.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Melanoma

Currently open trials in the same condition.

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