CRADLE for Leukocoria

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
St. Jude Children's Research Hospital, Memphis, TN
Leukocoria+5 More
CRADLE - Other
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a smartphone application called CRADLE (ComputeR Assisted Detection of LEukocoria) has the potential to improve the detection of leukocoria.

See full description

Eligible Conditions

  • Leukocoria
  • Developmental glaucoma
  • Retinoblastoma
  • Cataracts Infantile

Treatment Effectiveness

Study Objectives

This trial is evaluating whether CRADLE will improve 3 primary outcomes in patients with Leukocoria. Measurement will happen over the course of Day 1.

Day 1
Rate of detection of leukocoria using CRADLE
Up to Day 4
Sensitivity of CRADLE versus ophthalmoscope to detect leukocoria
Specificity of CRADLE versus ophthalmoscope to detect leukocoria

Trial Safety

Trial Design

3 Treatment Groups

Stratum I: Initial Evaluation Group
1 of 3
Stratum II: Leukocoria Evaluation Group
1 of 3
Stratum III: Retinoblastoma Group
1 of 3
Experimental Treatment

This trial requires 290 total participants across 3 different treatment groups

This trial involves 3 different treatments. CRADLE is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Stratum I: Initial Evaluation Group
Other
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.
Stratum II: Leukocoria Evaluation GroupA 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 GroupA 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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to day 4
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to day 4 for reporting.

Closest Location

St. Jude Children's Research Hospital - Memphis, TN

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. You must have received newly diagnosed for Leukocoria or one of the other 5 conditions listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient has retinoblastoma and has not yet had surgery to remove their eye (enucleation) show original
The patient has been diagnosed with congenital cataracts, congenital glaucoma, or retinoblastoma and is scheduled for a visit with an ophthalmologist. show original
A patient with retinoblastoma is receiving ocular salvage treatment. show original
The patient has not received any previous therapy for cataracts or glaucoma. show original
The patient has been referred for ophthalmological evaluation, including a check for leukocoria or any other conditions. show original

Patient Q&A Section

How many people get retinoblastoma a year in the United States?

"Retinoblastoma is an extremely rare tumor which, if treated appropriately with surgery, high doses of radiation, and chemotherapy, has a very low risk for spread. Consequently, in large US populations, retinoblastoma typically may be the most lethal form of cancer for females, but the very low risk of cancer-related death appears to be the greatest advantage to female patients, as seen in other countries." - Anonymous Online Contributor

Unverified Answer

Can retinoblastoma be cured?

"There is no evidence that retinoblastoma can be cured. On the contrary, in some cases (approximately one-third of childhood cases) the disease may become more severe despite the use of intensive initial chemotherapy, necessitating an even higher treatment intensity when the child is older (i.e. in adolescence, when the disease is more metastatic)." - Anonymous Online Contributor

Unverified Answer

What causes retinoblastoma?

"The retinoblastoma risk is affected by age, race, socioeconomic status, parental history, and other inherited factors. It has not yet been determined what causes retinoblastoma to occur by itself. It has not been established why some people develop retinoblastoma at only one time in their lifetime and more than one person in their family may develop retinoblastoma at different times. It is not known why some people who develop retinoblastoma are at a significant risk of developing and other people are more resistant to developing retinoblastoma. Many people with retinoblastoma have had one or more cancers that had cancer-causing genomic alterations." - Anonymous Online Contributor

Unverified Answer

What are common treatments for retinoblastoma?

"The most common treatment for retinoblastoma is enucleation, which is usually accompanied by radiotherapy and chemotherapy. External beam radiotherapy is commonly used to maximize the local destruction of cancer cells, while systemic therapy is used to minimize the effects and damage to normal cells. The type of chemotherapy agents used for metastatic retinoblastoma is also variable: doxorubicin, etoposide, and cisplatin are the commonly used agents. In addition, intraretinal and systemic chemotherapy treatments are used in combination with surgery, in case of progressive disease or in the presence of retinal vessel permeability." - Anonymous Online Contributor

Unverified Answer

What are the signs of retinoblastoma?

"Children that have retinoblastomas are more likely to have one or more of the following symptoms: fever, vomiting, blood in stool, vomiting blood, stomach ache or pain, bleeding gums, lump or growth in the breast, stomach pains, lump in the breast, or sore throat. The commonest and most frightening symptom for children is a lump or growth in the breast. The most common symptom of retinoblastoma is a lump or growth in a socket of the eye." - Anonymous Online Contributor

Unverified Answer

What is retinoblastoma?

"The common cancer with the highest number of cancer deaths worldwide is retinoblastoma, which is most lethal in developing countries. The primary cancer of children with the lowest number of cancer deaths worldwide is lung cancer. Retinoblastoma was the cause of around 5.3 of the 10,000 cancer-related deaths worldwide in 1999. Retinoblastoma is more common among children than adults, and this reflects the increasing life expectancy in the developing world. The survival rate in developing countries is much lower than in industrialized countries. There are variations across the globe. In the US, the five-year survival rate is nearly 90% while in Kenya, it is approximately 20%. Survival rates for other European countries are even lower." - Anonymous Online Contributor

Unverified Answer

What is the latest research for retinoblastoma?

"Although it remains the most common childhood cancer, the use of chemotherapy for retinoblastomas has not expanded in the last 3-6 years. The incidence of other cancers has declined due to improved prognosis of certain nonmalignant tumors." - Anonymous Online Contributor

Unverified Answer

How does cradle work?

"Since the advent of Cradle, a new approach has been discovered that appears to decrease the risk of death at a younger age in patients with retinoblastoma. Additional studies are warranted to determine the ultimate effect of Cradle on the mortality of patients with retinoblastoma, as well as the incidence of other malignancies." - Anonymous Online Contributor

Unverified Answer

Does retinoblastoma run in families?

"The RR in family members of patients with retinoblastoma is approximately 4-fold higher than expected, and similar to those seen in hereditary nonpolyposis [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer), Li-Fraumeni syndrome, hereditary breast-ovarian cancer syndrome, and hereditary renal cell cancer. These families warrant genetic diagnosis." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in cradle for therapeutic use?

"The [CRB-4 CRT unit]] has been used clinically in the Netherlands and the United States; however, the use of CRB, as a whole, as part of multi-modality approach for treating CRB-4 expressing brain tumours has not been adopted outside the Netherlands. An important aspect of CRB use has been the observation and discussion of its risks and efficacy when used in a multi-modality setting. There was no apparent correlation between the CRB use and survival with the exception of the use of CRB in conjunction with surgical resection of the local disease." - Anonymous Online Contributor

Unverified Answer

Is cradle typically used in combination with any other treatments?

"Data from a recent study provided more than 160 cases of retinoblastomas treated using CRT in a clinical setting. The mean age at diagnosis of these tumors was 2 years and 6 months. The most common form of CRT was the standard CRT (56%), followed by CRT plus radiotherapy (33%). The mean tumor size was > or =5 mm in size (63%). No statistically significant relationships were found between any of the study clinicobiologic factors tested and outcome. Because CRT had never been used in clinical trials with retinoblastoma before, it was considered reasonable to test for its impact on disease behavior and survival." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating retinoblastoma?

"There have been some advances. At first glance, newer treatments seem promising until more data is absorbed. Treatments have improved in the ability to save eyes with less risk. It is important to maintain your own well-being, but it is important to educate yourself and your family as well. Be proactive with research and update your latest treatments at your medical visits. Do not wait for the next treatment, there may not be one. Get informed to find your current treatments." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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