NCT05308043

Brief Summary

Retinoblastoma is the most common eye cancer of childhood. Eye-preserving therapies require routine monitoring of retinoblastoma regression and recurrence to guide corresponding treatment. In the current study, we develop a deep learning algorism that can simultaneously identify retinoblastoma tumours on Retcam images and distinguish between active and inactive retinoblastoma tumours. This algorism will be validated through a prospectively collected dataset.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

2.2 years

First QC Date

March 24, 2022

Last Update Submit

March 24, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnosis accurcy of deep learning algorism

    The diagnosic accurcy of this deep learning algorism is the proportion of true positive and true negative in all evaluated cases

    1 week

Study Arms (1)

Retinoblastoma patients

Retinoblastoma patients who undergo standard medical care in Beijing Tongren Hospital. The anonymous image of these patients will be prospectively collected and labelled by senior ophthalmologists.

Diagnostic Test: Deep learning algorism

Interventions

Deep learning algorismDIAGNOSTIC_TEST

A deep learning algorism that was developed previous would be applied to identify retinoblastoma tumours on Retcam images and distinguish between active and inactive retinoblastoma tumours. The decision of two different senior ophthalmologists would be the gold standard.

Retinoblastoma patients

Eligibility Criteria

Age0 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Retinoblastoma patients undergo standard medical management.

You may qualify if:

  • Retinoblastoma patients undergo standard medical management.

You may not qualify if:

  • The operators identified images non-assessable for a correct diagnosis, due to reasons such as blur and defocus, and excluded them from further analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wen-Bin Wei

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

  • Zhang R, Dong L, Li R, Zhang K, Li Y, Zhao H, Shi J, Ge X, Xu X, Jiang L, Shi X, Zhang C, Zhou W, Xu L, Wu H, Li H, Yu C, Li J, Ma J, Wei W. Automatic retinoblastoma screening and surveillance using deep learning. Br J Cancer. 2023 Aug;129(3):466-474. doi: 10.1038/s41416-023-02320-z. Epub 2023 Jun 21.

MeSH Terms

Conditions

Retinoblastoma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueRetinal NeoplasmsEye NeoplasmsNeoplasms by SiteEye Diseases, HereditaryEye DiseasesRetinal Diseases

Central Study Contacts

Wenbin Wei, MD

CONTACT

Ruiheng Zhang, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

March 24, 2022

First Posted

April 1, 2022

Study Start

March 1, 2020

Primary Completion

May 1, 2022

Study Completion

October 1, 2022

Last Updated

April 1, 2022

Record last verified: 2022-03

Locations