Clinical trial NCT03016156: Determination of the Sensitivity and Specificity of a Smartphone Application to Detect Retinoblastoma
Official title: Determination of the Sensitivity and Specificity of a Smartphone Application to Detect Retinoblastoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Retinoblastoma
Cataracts Infantile
Glaucoma, Congenital
Leucocoria
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 290
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of detection of leukocoria using CRADLE
timeFrame: Day 1
measure: Sensitivity of CRADLE versus ophthalmoscope to detect leukocoria
timeFrame: Up to Day 4
measure: Specificity of CRADLE versus ophthalmoscope to detect leukocoria
timeFrame: Up to Day 4
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Carlos Rodriguez-Galindo, MD
role: PRINCIPAL_INVESTIGATOR
References: