Evaluating health outcomes in retinoblastoma patients after treatment
Research Into Visual Endpoints and RB Health Outcomes After Treatment (RIVERBOAT)
This study looks at the health and vision outcomes of people who have been treated for retinoblastoma to see how they are doing over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 900 (estimated) |
| Sex | All |
| Sponsor | Vanderbilt-Ingram Cancer Center Academic / other |
| Locations | 11 sites (Chicago, Illinois and 10 other locations) |
| Trial ID | NCT03932786 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on assessing health outcomes in patients who have undergone treatment for retinoblastoma. It involves collecting health information over time from patients and their family members through various methods, including vision assessments, tissue and saliva samples, and questionnaires. The study aims to define acute toxicity, subsequent malignant neoplasm risk, and visual outcomes in retinoblastoma survivors while also creating a biorepository for future research on genetic interactions related to the disease. Patients are divided into retrospective and prospective cohorts based on their treatment timelines.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with unilateral or bilateral intraocular retinoblastoma between the ages of 0 and 17.99 years.
Not a fit: Patients currently undergoing treatment or those with diminished capacity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into long-term health outcomes and optimal therapies for retinoblastoma survivors.
How similar studies have performed: Other studies have shown success in evaluating health outcomes in cancer survivors, making this approach promising yet still requiring further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
* Unilateral or bilateral intraocular retinoblastoma * Diagnosis between the ages of 0 - 17.99 years * Diagnosis on or after January 1, 2008 * No exclusions based on primary or secondary treatment modalities * Retrospective group patients must be ≥ 6 months post end of treatment at study entry * For those already at this timepoint, they are now eligible * For those in treatment, or otherwise not yet at this timepoint, they are eligible once at they are ≥ 6 months post end of treatment * Prospective group patients must not have begun treatment * Patients with diminished capacity will not be enrolled. * Language: Patients must be able to communicate in English, French, or Spanish * Sibling Cohort: One sibling, not affected by retinoblastoma will be enrolled, preference for the sibling closest in age to the RB patient. * Regulatory Requirements: All patients and/or their parents or legal guardians must sign a written informed consent. All institutional, FDA, and NCI requirements for human studies must be met.
Where this trial is running
Chicago, Illinois and 10 other locations
- Lurie Children's Hospital — Chicago, Illinois, United States (Recruiting)
- University of Illinois, Chicago — Chicago, Illinois, United States (Recruiting)
- University of Minnesoa — Minneapolis, Minnesota, United States (Recruiting)
- Washington School of Medicine at St. Louis — St Louis, Missouri, United States (Recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Texas Childeren's Hospital — Houston, Texas, United States (Recruiting)
- Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
- The Hosptial for Sick Children — Toronto, Canada (Recruiting)
Study contacts
- Principal investigator: Debra Friedman, MD — Vanderbilt Medical Center
- Study coordinator: Vanderbilt-Ingram Service for Timely Access
- Email: cip@vanderbilt.edu
- Phone: 800-811-8480
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.