Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-03-14 @ 5:53 AM
Study NCT ID:
NCT03016156
Status:
TERMINATED
Last Update Posted:
2025-11-07
First Post:
2016-12-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determination of the Sensitivity and Specificity of a Smartphone Application to Detect Retinoblastoma
Sponsor:
St. Jude Children's Research Hospital
Organization:
Study Overview
Official Title:
Determination of the Sensitivity and Specificity of a Smartphone Application to Detect Retinoblastoma
Status:
TERMINATED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Accrual was slow.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2021-05557 | REGISTRY | NCI | View |