Study Stopped
Study administratively closed at IRB prior to enrollment.
Photoscreening for Retinoblastoma
Prospective Evaluation of a Smartphone Application, GoCheckKids TM, as a Screening Tool for Leukocoria in the Infant and Pediatric Population
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
Retinoblastoma is the most common pediatric eye malignancy and manifests between 1 and 5 years of age. The tumor is most often diagnosed by leukocoria ( white reflex in the pupil). There is often a significant delay in diagnosis and early diagnosis enables good life prognosis and better vision outcome.There is currently not a standardized screening protocol for detection of retinoblastoma. Vision screening methods are recommended for children 3-5 years of age. The investigators are attempting to use instrument based screening started from birth to detect leukocoria.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2020
CompletedFirst Posted
Study publicly available on registry
April 14, 2020
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedSeptember 26, 2025
April 1, 2020
Same day
April 9, 2020
September 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Reliability to detect leukocoria
Testing the reliability of the app to detect leukocoria with good sensitivity and specificity
1 year
Study Arms (1)
Photoscreening
EXPERIMENTALPhotoscreening of patients 0 to 10 years of age
Interventions
Eligibility Criteria
You may qualify if:
- Age birth to 10 years
- Informed consent given by parent or legal guardian
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2020
First Posted
April 14, 2020
Study Start
June 1, 2022
Primary Completion
June 1, 2022
Study Completion
June 1, 2022
Last Updated
September 26, 2025
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share