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Sponsor study identifier
observational
535
1 country
1
Study Start
December 5, 2022
Actual (reported)Primary Completion
June 5, 2023
Actual (reported)Study Completion
June 5, 2023
Actual (reported)Rare diseases generally refer to diseases whose prevalence rate is lower than 1 / 10 000 and the number of patients is less than 140000. Rare diseases are generally faced with the dilemma of a lack of qualified doctors, difficulty in large-scale screening, and a lack of rapid and effective channels for medical treatment. Studies have shown that 42% of patients say they have been misdiagnosed, and each patient with a rare disease needs to go through an average of eight doctors in seven years to see a corresponding rare disease specialist. More importantly, most rare diseases seriously affect the health and quality of life of patients. The ocular surface malignant tumor is a typical rare disease, and its incidence is less than 1 / 100000. The ocular surface not only affects the patient's appearance, but also damages the visual function, and the malignant tumor may even affect life. These uncommon malignant tumors are often hidden in the common black nevus on the eye surface, which is easy to be ignored and has great potential risks. With the improvement of people's living standards, people start to pay attention to rare diseases. In recent years, the rapid development of digital technology has also provided new opportunities for the prevention and treatment of rare diseases. Our team established the database of rare ophthalmopathy in China in the early stage, which provided a solid foundation for the digitization of precious clinical data. This study intends to develop an intelligent screening system for ocular surface malignant tumors, using the mobile phone for real-world verification and scale screening, and explore it to improve the ability of doctors to diagnose and treat rare diseases. This study is expected to improve the ability to screen malignant tumors on the ocular surface and provide a novel model for the universal screening of rare diseases.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 5, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2, 2022
Actual (reported)December 5, 2022
Actual (reported)December 9, 2022
Actual (reported)June 5, 2023
Actual (reported)June 5, 2023
Actual (reported)Area under the curve (AUC)
Measure of the ability of a binary classifier to distinguish between malignent and benign.
2024.1
Sensitivity, specificity and accuracy
2024.1
Screening coverage
2024.1
Referral efficiency
2024.1
Human-machine collaboration performance
2024.1
Develop an intelligent screening system for ocular surface malignant tumors, apply it to the mobile terminal for real-world verification and large-scale general screening, and test its effect on assisting doctors in the diagnosis and treatment of rare diseases.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Through the offline specialist clinics, online popular science, news reports, and other channels, we will promote and inform the crowd about the relevant knowledge of pigmented tumors on the ocular surface, so that they can judge by themselves that they are eligible to join the group, and freely decide whether to participate in this study or not.
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
Wang R, Bi S, Lin D, Li M, Zhao L, Zhou Y, Jin L, Chen W, Li R, Shang Y, Yang H, Chen R, Xiao W, Ai S, Li J, Ling S, Wu X, Li Z, Liu G, Lu Y, Lin W, Rao H, Meng X, Yan H, Nie C, Zhu M, Ye H, Lin H. Smartphone-Based Proactive Self-Screening for Ocular Surface Malignancies: A Nonrandomized Clinical Trial. JAMA Ophthalmol. 2026 Jul 1;144(7):627-635. doi: 10.1001/jamaophthalmol.2026.1609.
535 participants (actual enrollment reported by the registry).
First Submitted
December 2, 2022
First Posted
December 9, 2022
Study Start
December 5, 2022
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
June 5, 2023
Actual (reported)Study Completion
June 5, 2023
Actual (reported)Last Updated
August 5, 2024
Record last verified: 2024-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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