Photoscreening for Retinoblastoma

Sponsor

Phoenix Children's Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04344652

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinoblastoma	Device: Photoscreening -	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

76 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single visit cross sectional prospective studySingle visit cross sectional prospective study

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

May 31, 2021

Anticipated Study Completion Date :

May 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Photoscreening Photoscreening of patients 0 to 10 years of age	Device: Photoscreening - external picture taken with a an phone based app

Arm

Intervention/Treatment

Experimental: Photoscreening

Photoscreening of patients 0 to 10 years of age

Device: Photoscreening -

external picture taken with a an phone based app

Outcome Measures

Primary Outcome Measures

Reliability to detect leukocoria [1 year]
Testing the reliability of the app to detect leukocoria with good sensitivity and specificity

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age birth to 10 years
Informed consent given by parent or legal guardian

Exclusion Criteria:

None

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Phoenix Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Phoenix Children's Hospital

ClinicalTrials.gov Identifier:

NCT04344652

Other Study ID Numbers:

AR01

First Posted:

Apr 14, 2020

Last Update Posted:

Apr 14, 2020

Last Verified:

Apr 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Retinoblastoma

Study Results

No Results Posted as of Apr 14, 2020