Clinical trial · Interventional
Determination of the Sensitivity and Specificity of a Smartphone Application to Detect Retinoblastoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Why stopped (as posted): Accrual was slow.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cataracts Infantile | — | UNRESOLVED | — |
| Glaucoma, Congenital | — | UNRESOLVED | — |
| Leucocoria | — | UNRESOLVED | — |
| Retinoblastoma | Retinoblastoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CRADLE | Other | — | UNRESOLVED |
| Red reflex testing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Stratum I: Initial Evaluation Group
- description
- Initially, a small group of patients diagnosed with congenital or infantile cataracts, congenital glaucoma or retinoblastoma and who meet the eligibility criteria will undergo testing with CRADLE on Day 1.
- interventionNames
- Other: CRADLE
- type
- EXPERIMENTAL
- label
- Stratum II: Leukocoria Evaluation Group
- description
- A separate group of participants who are referred for evaluation of leukocoria or any other eye condition will undergo red reflex testing testing with CRADLE on Day 1.
- interventionNames
- Other: CRADLE
- Other: Red reflex testing
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 7 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available