Actively Recruiting
Research Into Visual Endpoints and RB Health Outcomes After Treatment (RIVERBOAT)
Led by Vanderbilt-Ingram Cancer Center · Updated on 2025-09-19
900
Participants Needed
11
Research Sites
52 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt-Ingram Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying health outcomes in patients who have been treated for retinoblastoma, a type of eye cancer. The study aims to understand acute treatment side effects, the risk of developing new cancers, visual outcomes, and psychosocial and physical effects in survivors compared to healthy siblings and standard data. The trial also explores genetic factors influencing disease and treatment responses through a specially annotated biorepository of patient tissues and DNA samples. Participants join one of two groups based on their treatment timeline. The retrospective group includes patients treated between 2008 and 2018 who provide saliva samples at least six months after treatment, undergo vision assessments, and complete questionnaires. The prospective group includes patients treated between 2018 and 2023 who provide saliva and tissue samples, undergo vision assessments at enrollment and follow-up times, and complete questionnaires. Immediate family members with retinoblastoma or the RB1 gene mutation may also provide saliva samples. During the study, participants undergo vision tests, provide tissue and saliva samples, and complete psychosocial and quality-of-life questionnaires at various times up to two years after treatment. Researchers will analyze genetic information and monitor acute toxicity and long-term outcomes through medical records and assessments. The total duration of participation varies with follow-up visits occurring up to two years after treatment, allowing comprehensive monitoring of health and vision outcomes.
CONDITIONS
Brief Title
Studying Health Outcomes After Treatment in Patients With Retinoblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with unilateral or bilateral intraocular retinoblastoma
- Diagnosis made between ages 0 and 17.99 years
- Diagnosis date on or after January 1, 2008
- Retrospective group patients must be at least 6 months post-treatment at study entry
- Prospective group patients must not have started treatment yet
- Ability to communicate in English, French, or Spanish
- One sibling without retinoblastoma may be enrolled, preferably closest in age to the patient
- Written informed consent obtained from patient or legal guardian
- Compliance with all regulatory requirements for human studies
You will not qualify if you...
- Patients with diminished capacity to participate
- Patients not meeting language communication requirements
- Patients who have not reached 6 months post-treatment for retrospective group
- Patients who have begun treatment for the prospective group
- Failure to provide informed consent or comply with regulatory requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - At enrollment and up to 2 years after treatment
Participants undergo collection of saliva and tissue samples, vision assessments, and complete questionnaires depending on cohort assignment.
1 to 2 visits depending on cohort and timepoints (enrollment, 6 months, 18 months, and 2 years)
Duration - Up to 2 years after treatment
Participants are followed for up to 2 years post-treatment to assess visual outcomes, psychosocial and neurocognitive outcomes, and quality of life through questionnaires and vision assessments.
Follow-up visits at 6 months, 1 year, 18 months, and 2 years depending on cohort
Trial Site Locations
Total: 11 locations
1
Lurie Children's Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
2
University of Illinois, Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
3
University of Minnesoa
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
4
Washington School of Medicine at St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
5
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
6
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
7
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
8
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
9
Texas Childeren's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
10
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
11
The Hosptial for Sick Children
Toronto, Canada
Actively Recruiting
Research Team
V
Vanderbilt-Ingram Service for Timely Access
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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