TerminatedNot Applicable

Determination of the Sensitivity and Specificity of a Smartphone Application to Detect Retinoblastoma

Stopped: Accrual was slow.

United States1 participantsStarted 2018-03-15

Plain-language summary

This study seeks to determine whether a smartphone application called CRADLE (ComputeR Assisted Detection of LEukocoria) has the potential to improve the detection of leukocoria. There will be no impact on participants' health outcome. This study will be performed in two parts, each with a distinct cohort of patients. Part 1 will assess the feasibility of various techniques/conditions for using CRADLE within patients known to have leukocoria. Part 2 will estimate the sensitivity and specificity of CRADLE to detect leukocoria (using the techniques selected from information gathered in Part 1) as compared to an ophthalmoscope, within patients referred to the clinic for suspected leukocoria. PRIMARY OBJECTIVES: * To determine the most effective usage of a camera phone application (CRADLE) to maximize detection of leukocoria in patients with retinoblastoma, congenital cataracts, and glaucoma. * To estimate the sensitivity and specificity of a camera phone application (CRADLE) in detecting leukocoria.

Who can participate

Age range7 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria - Stratum I: * Patient has been diagnosed with congenital or infantile cataracts, congenital glaucoma, or retinoblastoma, and is scheduled for a visit with an ophthalmologist at St. Jude Children's Research Hospital or University of Tennessee Hamilton Eye Institute. * Patient with retinoblastoma is newly diagnosed, or has received \< 2 cycles of chemoreductive therapy, and has not undergone enucleation. * Patient with cataracts or glaucoma has not received any prior therapy. Inclusion Criteria - Stratum II: * Patient without prior diagnosis has been referred for ophthalmological evaluation, including leukocoria or other conditions. Inclusion Criteria - Stratum III: * Patient with retinoblastoma undergoing ocular salvage treatment. Exclusion Criteria * Prior treatment for cataracts or glaucoma * Inability or unwillingness of research participant or legal guardian to consent.

What they're measuring

Rate of detection of leukocoria using CRADLE

Timeframe: Day 1

Sensitivity of CRADLE versus ophthalmoscope to detect leukocoria

Timeframe: Up to Day 4

Specificity of CRADLE versus ophthalmoscope to detect leukocoria

Timeframe: Up to Day 4

Trial details

NCT IDNCT03016156

SponsorSt. Jude Children's Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-30