Photoscreening for Retinoblastoma

Retinoblastoma Clinical Trial

Official title:

Prospective Evaluation of a Smartphone Application, GoCheckKids TM, as a Screening Tool for Leukocoria in the Infant and Pediatric Population

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04344652
• Other study ID #: AR01
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: April 2020
• Source: Phoenix Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 10 Years

Eligibility

Inclusion Criteria:

• Age birth to 10 years

• Informed consent given by parent or legal guardian

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Retinoblastoma

Intervention

Device:
• Photoscreening -
external picture taken with a an phone based app

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Phoenix Children's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliability to detect leukocoria	Testing the reliability of the app to detect leukocoria with good sensitivity and specificity	1 year