Validation of the Utility of Rare Disease Intelligence Platform

Validation of the Utility of Rare Disease Intelligence Platform: A Multicenter Cluster Clinical Trial

The prevention and treatment of diseases via artificial intelligence represents an ultimate goal in computational medicine. The artificial intelligence for systematic clinical application has not yet been successfully validated. Currently, the main prevention strategy for rare diseases is to build specialized care centers. However, these centers are scattered, and their coverage is insufficient, resulting in inadequate health care among a large proportion of rare disease patients. Here, the investigators use "deep learning" to create CC-Cruiser, an intelligence agent involving three functional networks: "pick-up networks" for diagnostics, "evaluation networks" for risk stratification and "strategist networks" to provide assisted treatment decisions. The investigator also establish a cloud intelligence platform for multi-hospital collaboration and conduct clinical trial and website-based study to validate its versatility.

Study Overview

• Status: Completed
• Conditions: Cataract; Artificial Intelligence
• Intervention / Treatment: Device: CC-Cruiser

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Zhongshan Ophthalmic Center, Sun Yat-sen University
    • Guangzhou, Guangdong, China, 510080
      • Department of Ophthalmology, Guangdong General Hospital, Guangdong Academy of Medical Sciences
    • Guangzhou, Guangdong, China, 510405
      • Department of Ophthalmology, First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
    • Qingyuan, Guangdong, China, 511518
      • Department of Ophthalmology, Qingyuan People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who underwent ophthalmic examination of the eye and recorded their ocular information in the collaborating hospital.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eligible patients for CC-Cruiser test	Device: CC-Cruiser; An artificial intelligence to make comprehensive evaluation and treatment decision of congenital cataracts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of accurate, mistaken and miss detection of CC-Cruiser.	Up to 4 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Ministry of Health, China; Xidian University
• Investigators: Principal Investigator: Erping Long, M.D., Ph.D, Zhongshan Ophthalmic Center, Sun Yat-sen University; Study Director: Haotian Lin, M.D., Ph.D, Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications and helpful links

General Publications

• Lin H, Long E, Chen W, Liu Y. Documenting rare disease data in China. Science. 2015 Sep 4;349(6252):1064. doi: 10.1126/science.349.6252.1064-b. No abstract available.
• Lin H, Ouyang H, Zhu J, Huang S, Liu Z, Chen S, Cao G, Li G, Signer RA, Xu Y, Chung C, Zhang Y, Lin D, Patel S, Wu F, Cai H, Hou J, Wen C, Jafari M, Liu X, Luo L, Zhu J, Qiu A, Hou R, Chen B, Chen J, Granet D, Heichel C, Shang F, Li X, Krawczyk M, Skowronska-Krawczyk D, Wang Y, Shi W, Chen D, Zhong Z, Zhong S, Zhang L, Chen S, Morrison SJ, Maas RL, Zhang K, Liu Y. Lens regeneration using endogenous stem cells with gain of visual function. Nature. 2016 Mar 17;531(7594):323-8. doi: 10.1038/nature17181. Epub 2016 Mar 9. Erratum In: Nature. 2017 Jan 26;541(7638):558.

Helpful Links

• Home page of Zhongshan Ophthalmic Center
• Homepage of Childhood Cataract Program of the Chinese Ministry of Health(CCPMOH)

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: April 13, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimate): April 22, 2016

Study Record Updates

• Last Update Posted (Estimate): April 22, 2016
• Last Update Submitted That Met QC Criteria: April 21, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease Attributes; Lens Diseases; Cataract; Rare Diseases
• Other Study ID Numbers: CCPMOH2016-China3