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Photoscreening for Retinoblastoma

Primary Purpose

Retinoblastoma

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Photoscreening -

About this trial

This is an interventional diagnostic trial for Retinoblastoma

Eligibility Criteria

undefined - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

None

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Photoscreening

Arm Description

Photoscreening of patients 0 to 10 years of age

Outcomes

Primary Outcome Measures

Reliability to detect leukocoria

Testing the reliability of the app to detect leukocoria with good sensitivity and specificity

Secondary Outcome Measures

Full Information

NCT ID

NCT04344652

First Posted

April 9, 2020

Last Updated

April 13, 2020

Sponsor

Phoenix Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04344652

Brief Title

Photoscreening for Retinoblastoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2020 (Anticipated)

Primary Completion Date

May 31, 2021 (Anticipated)

Study Completion Date

May 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Phoenix Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinoblastoma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single visit cross sectional prospective study

Masking

None (Open Label)

Allocation

N/A

Enrollment

76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Photoscreening

Arm Type

Experimental

Arm Description

Photoscreening of patients 0 to 10 years of age

Intervention Type

Device

Intervention Name(s)

Photoscreening -

Intervention Description

external picture taken with a an phone based app

Primary Outcome Measure Information:

Title

Reliability to detect leukocoria

Description

Testing the reliability of the app to detect leukocoria with good sensitivity and specificity

Time Frame

1 year

10. Eligibility

Sex

All

Gender Based

Yes

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age birth to 10 years Informed consent given by parent or legal guardian Exclusion Criteria: None

12. IPD Sharing Statement

Learn more about this trial

Photoscreening for Retinoblastoma

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