NCT03932786

Studying Health Outcomes After Treatment in Patients With Retinoblastoma

Research Into Visual Endpoints and RB Health Outcomes After Treatment (RIVERBOAT)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 900 (estimated)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This trial studies health outcomes after treatment in patients with retinoblastoma. Gathering health information over time from patients and family members through vision assessments, samples of tissue and saliva, and questionnaires may help doctors learn more about what causes retinoblastoma, identify long-term health outcomes for patients with retinoblastoma, and find out which therapies may be the best for treating retinoblastoma

Detailed description

PRIMARY OBJECTIVES: I. Define acute toxicity, subsequent malignant neoplasm (SMN) risk and visual outcomes in retinoblastoma (RB) survivors and compare patient centered psychosocial and neurocognitive and physical outcomes in survivors with normative data and sibling controls. II. Create the first Clinically-Annotated Patient Tissues to Analyze Gene INteractions to assess biologic correlates of disease and facilitate future research: The RIVERBOAT-CAPTAIN biorepository, including germline deoxyribonucleic acid (DNA) and tumor tissue from patients, with detailed patient, disease and treatment-related information. III. Using the RIVERBOAT-CAPTAIN clinically-annotated biorepository, determine the interplay between specific RB1 mutation type and the role of additional modifier genes in determining those tumor phenotypes that drive treatment decisions. OUTLINE: Patients are assigned to 1 of 2 cohorts. RETROSPECTIVE COHORT: Patients treated between 2008-2018 undergo collection of saliva samples at \>= 6 months after treatment, and undergo vision assessment at \>= 6 months after treatment and again 1 year later if necessary. Previously collected tissue samples at the time of surgery are also obtained. Patients also complete questionnaires at \>= 6 months after treatment and again 2 years later. PROSPECTIVE COHORT: Patients treated between 2018-2023 undergo collection of saliva samples at the time of enrollment and at 6 months after treatment. Patients also undergo vision assessment at the time of enrollment, at 6 months, and 18 months after completion of treatment. Patients also complete questionnaires at 6 months and again 2 years later, as well as undergo collection of tissue samples at the time of surgery. Immediate family members with history of RB or RB1 gene mutation also undergo collection saliva samples.

Conditions

• Retinoblastoma
• Cancer Survivor
• Biological Sibling
• Intraocular Retinoblastoma
• Unilateral Retinoblastoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen collection	Collection of tissue and saliva samples
OTHER	Vision assessment	Undergo vision assessment
OTHER	Questionnaire administration	Complete questionnaires
OTHER	Quality of life assessment	Complete questionnaires
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2019-01-24
• Primary completion: 2030-01-01
• Completion: 2031-01-01
• First posted: 2019-05-01
• Last updated: 2025-09-19

Locations

11 sites across 2 countries: United States, Canada