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Smartphone App Detection for Retinoblastoma

N/A

Recruiting

Led By Carlos Rodriguez-Galindo, MD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stratum III: Patient with retinoblastoma undergoing ocular salvage treatment.

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 4

Awards & highlights

Study Summary

This trial will assess the feasibility and potential of a smartphone application to improve the detection of leukocoria.

Who is the study for?

This trial is for patients with retinoblastoma, congenital cataracts, or glaucoma who are visiting St. Jude Children's Research Hospital or University of Tennessee Hamilton Eye Institute. It includes new or minimally treated retinoblastoma cases and those referred for eye conditions like leukocoria.Check my eligibility

What is being tested?

The study tests the CRADLE smartphone app's ability to detect leukocoria compared to traditional red reflex testing using an ophthalmoscope. The trial has two parts: finding the best way to use CRADLE and measuring its accuracy (sensitivity and specificity).See study design

What are the potential side effects?

Since this study involves a diagnostic tool that does not impact health outcomes directly, there are no anticipated side effects from participating in this clinical trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am receiving treatment to save my eye from retinoblastoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of detection of leukocoria using CRADLE

Sensitivity of CRADLE versus ophthalmoscope to detect leukocoria

Specificity of CRADLE versus ophthalmoscope to detect leukocoria

Trial Design

3Treatment groups

Experimental Treatment

Group I: Stratum III: Retinoblastoma GroupExperimental Treatment2 Interventions

A separate group of participants with known retinoblastoma and who are undergoing ocular salvage treatments will be screened with red reflex testing using direct ophthalmoscopy on Day 1. They will also undergo testing with the CRADLE software application defined as the most effect in Stratum I on Day 1 then for three additional consecutive visits which typically occur every 3 to 4 weeks.

Group II: Stratum II: Leukocoria Evaluation GroupExperimental Treatment2 Interventions

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.

Group III: Stratum I: Initial Evaluation GroupExperimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor

429 Previous Clinical Trials

5,306,468 Total Patients Enrolled

9 Trials studying Retinoblastoma

4,374 Patients Enrolled for Retinoblastoma

Carlos Rodriguez-Galindo, MDPrincipal InvestigatorSt. Jude Children's Research Hospital

6 Previous Clinical Trials

1,734 Total Patients Enrolled

3 Trials studying Retinoblastoma

203 Patients Enrolled for Retinoblastoma

Media Library

CRADLE Clinical Trial Eligibility Overview. Trial Name: NCT03016156 — N/A

Retinoblastoma Research Study Groups: Stratum III: Retinoblastoma Group, Stratum I: Initial Evaluation Group, Stratum II: Leukocoria Evaluation Group

Retinoblastoma Clinical Trial 2023: CRADLE Highlights & Side Effects. Trial Name: NCT03016156 — N/A

CRADLE 2023 Treatment Timeline for Medical Study. Trial Name: NCT03016156 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment currently available for this trial?

"This medical trial, which was first launched in March 15th 2018 and amended on October 3rd 2022, is not presently registering patients. However, there are currently 158 other ongoing trials that are open for enrolment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "Determination of the Sensitivity and Specificity of a Smartphone Application to Detect Retinoblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03016156.

All > Retinoblastoma > Cataract