RetinoblastomaNCT03016156
Determination of the Sensitivity and Specificity of a Smartphone Application to Detect Retinoblastoma
A study testing CRADLE and Red reflex testing in people with Retinoblastoma and Cataracts Infantile, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Retinoblastoma, Cataracts Infantile, Glaucoma, Congenital
- What is being tested?
- CRADLE and Red reflex testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2018to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Prior treatment for cataracts or glaucoma
- Inability or unwillingness of research participant or legal guardian to consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
About this study
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.
Read more
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.
Read the detailed description
This study will utilize three strata called Stratum I, Stratum II and Stratum III.
STRATUM I - Infants and children known to have leukocoria who have been diagnosed with retinoblastoma, cataracts or glaucoma or other eye conditions.
Participants enrolled on Stratum I of the study will have the CRADLE application used by the doctor during their appointment.
The participant will look straight forward while the doctor stands about 1-3 feet away holding the device that has the CRADLE application. He or she will slowly move the device up, down, middle, right, and left - both in a lit and dimmed room.
The participant will be videotaped and photographed during this appointment. The doctor will record the results as determined by CRADLE ("normal" or no leukocoria versus "abnormal" or positive for leukocoria).
STRATUM II - Infants and children who are referred to an eye doctor to evaluate for leukocoria.
Participants enrolled on Stratum II of the study will be asked to look straight forward while he or she uses the CRADLE application (using the best method determined from Stratum I). The doctor will also examine the participant's eyes with the ophthalmoscope method. The results from both CRADLE and the ophthalmoscope method will be recorded and compared (white eye present versus absent, and normal versus abnormal as described above).
STRATUM III - Infants and children receiving treatment for retinoblastoma. For participants enrolled on Stratum III, he or she will have the same procedures as described in Stratum II.
After receiving informed consent, participants will undergo evaluation by ophthalmoscope and CRADLE on Day 1. Stratum III participants only will also undergo CRADLE evaluation on Days 2, 3, and 4.
- Conditions
- Retinoblastoma, Cataracts Infantile, Glaucoma, Congenital, Leucocoria
- Being tested
- CRADLE, Red reflex testing
- Medical subject headings
- Retinoblastoma, Hydrophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRADLEOther
Also called Smartphone application, ComputeR Assisted Detection of LEukocoria
A smartphone software application designed to detect leukocoria using a sophisticated photoluminic analysis.
The investigator or designee will perform tests with CRADLE in separate patient cohorts with known diagnosis of retinoblastoma, congenital glaucoma, or cataracts.
Red reflex testingOther
Also called Ophthalmoscopic exam
Traditional red reflex testing for leukocoria using a direct ophthalmoscope on routine eye examination. Red reflex testing via direct ophthalmoscope will be performed before dilation, using the ophthalmoscope held close to the examiner's eye, focused on the pupil, viewed at 12 to 18 inches from the patient's eyes, with the room lights dimmed, in accordance with the American Academy of Pediatrics guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Stratum I: Initial Evaluation Group | Experimental | 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. Receives: Other: CRADLE |
| Stratum II: Leukocoria Evaluation Group | Experimental | 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. Receives: Other: CRADLE; Other: Red reflex testing |
| Stratum III: Retinoblastoma Group | Experimental | 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. Receives: Other: CRADLE; Other: Red reflex testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of detection of leukocoria using CRADLE
This outcome will assess the feasibility of various techniques and conditions for using CRADLE in participants with retinoblastoma, congenital cataracts, and glaucoma. The most effective usage of CRADLE to maximize detection of leukocoria will be determined by review of all images, and the most effective and efficient technique will be selected based on the findings and the clarity of the images. This technique will be used for completion of the subsequent objectives using a new cohort of participants.
Measured: Day 1
Sensitivity of CRADLE versus ophthalmoscope to detect leukocoria
The test results obtained by CRADLE will be compared to those obtained by ophthalmoscopic examination to determine the effectiveness of detection of leukocoria by CRADLE. The results will be reported as number of true positive. An ideal test for sensitivity has no false positives.
Measured: Up to Day 4
Specificity of CRADLE versus ophthalmoscope to detect leukocoria
The test results obtained by CRADLE will be compared to those obtained by ophthalmoscopic examination to determine the effectiveness of detection of leukocoria by CRADLE. The results will be reported as number of false negatives (specificity). An ideal test for sensitivity has no false negatives.
Measured: Up to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start15 Mar 2018
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Why it stopped: Accrual was slow.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetinoblastomaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Rodriguez-Galindo, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016156
- Sponsor's protocol ID
- RBAPP
- Other IDs
- NCI-2021-05557
- Status last verified
- Sep 2026
- First submitted
- 28 Dec 2016
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Sensitivity and Specificity of a Smartphone Application to Detect Retinoblastoma
- ClinicalTrials.gov ID
- NCT03016156
- Acronym / sponsor ID
- RBAPP
- Conditions
- Retinoblastoma, Cataracts Infantile, Glaucoma, Congenital, Leucocoria
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Accrual was slow.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will utilize three strata called Stratum I, Stratum II and Stratum III.
STRATUM I - Infants and children known to have leukocoria who have been diagnosed with retinoblastoma, cataracts or glaucoma or other eye conditions.
Participants enrolled on Stratum I of the study will have the CRADLE application used by the doctor during their appointment.
The participant will look straight forward while the doctor stands about 1-3 feet away holding the device that has the CRADLE application. He or she will slowly move the device up, down, middle, right, and left - both in a lit and dimmed room.
The participant will be videotaped and photographed during this appointment. The doctor will record the results as determined by CRADLE ("normal" or no leukocoria versus "abnormal" or positive for leukocoria).
STRATUM II - Infants and children who are referred to an eye doctor to evaluate for leukocoria.
Participants enrolled on Stratum II of the study will be asked to look straight forward while he or she uses the CRADLE application (using the best method determined from Stratum I). The doctor will also examine the participant's eyes with the ophthalmoscope method. The results from both CRADLE and the ophthalmoscope method will be recorded and compared (white eye present versus absent, and normal versus abnormal as described above).
STRATUM III - Infants and children receiving treatment for retinoblastoma. For participants enrolled on Stratum III, he or she will have the same procedures as described in Stratum II.
After receiving informed consent, participants will undergo evaluation by ophthalmoscope and CRADLE on Day 1. Stratum III participants only will also undergo CRADLE evaluation on Days 2, 3, and 4.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stratum I: Initial Evaluation Group | Experimental | Other: CRADLEInitially, 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. |
| Stratum II: Leukocoria Evaluation Group | Experimental | Other: CRADLE, Other: Red reflex testingA 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. |
| Stratum III: Retinoblastoma Group | Experimental | Other: CRADLE, Other: Red reflex testingA 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. |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Prior treatment for cataracts or glaucoma
- Inability or unwillingness of research participant or legal guardian to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRADLEAlso: Smartphone application, ComputeR Assisted Detection of LEukocoriaA smartphone software application designed to detect leukocoria using a sophisticated photoluminic analysis. The investigator or designee will perform tests with CRADLE in separate patient cohorts with known diagnosis of retinoblastoma, congenital glaucoma, or cataracts. | Other | Stratum I: Initial Evaluation Group, Stratum II: Leukocoria Evaluation Group, Stratum III: Retinoblastoma Group |
| Red reflex testingAlso: Ophthalmoscopic examTraditional red reflex testing for leukocoria using a direct ophthalmoscope on routine eye examination. Red reflex testing via direct ophthalmoscope will be performed before dilation, using the ophthalmoscope held close to the examiner's eye, focused on the pupil, viewed at 12 to 18 inches from the patient's eyes, with the room lights dimmed, in accordance with the American Academy of Pediatrics guidelines. | Other | Stratum II: Leukocoria Evaluation Group, Stratum III: Retinoblastoma Group |
Primary outcome
Rate of detection of leukocoria using CRADLE
Time frame: Day 1
This outcome will assess the feasibility of various techniques and conditions for using CRADLE in participants with retinoblastoma, congenital cataracts, and glaucoma. The most effective usage of CRADLE to maximize detection of leukocoria will be determined by review of all images, and the most effective and efficient technique will be selected based on the findings and the clarity of the images. This technique will be used for completion of the subsequent objectives using a new cohort of participants.
Sensitivity of CRADLE versus ophthalmoscope to detect leukocoria
Time frame: Up to Day 4
The test results obtained by CRADLE will be compared to those obtained by ophthalmoscopic examination to determine the effectiveness of detection of leukocoria by CRADLE. The results will be reported as number of true positive. An ideal test for sensitivity has no false positives.
Specificity of CRADLE versus ophthalmoscope to detect leukocoria
Time frame: Up to Day 4
The test results obtained by CRADLE will be compared to those obtained by ophthalmoscopic examination to determine the effectiveness of detection of leukocoria by CRADLE. The results will be reported as number of false negatives (specificity). An ideal test for sensitivity has no false negatives.
Results and safety
The study was stopped early (reason given: Accrual was slow.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Rodriguez-Galindo, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRADLE and Red reflex testing in people with Retinoblastoma and Cataracts Infantile, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Accrual was slow.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of detection of leukocoria using CRADLE (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.