NCT03016156Terminated
Determination of the Sensitivity and Specificity of a Smartphone Application to Detect Retinoblastoma
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Study type
- Interventional
- Enrollment
- 1 (actual)
- First submitted
- 28 Dec 2016
- Start date
- 15 Mar 2018
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- St. Jude Children's Research Hospital
- Diseases
- Glaucoma, Childhood cancers
- NCT number
- NCT03016156
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment for cataracts or glaucoma
Other
- Inability or unwillingness of research participant or legal guardian to consent.
Who the study is looking for
- 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.
- Patient without prior diagnosis has been referred for ophthalmological evaluation, including leukocoria or other conditions.
- Patient with retinoblastoma undergoing ocular salvage treatment.
Age in the registry: - to 7 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.