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Studying Health Outcomes After Treatment in Patients With Retinoblastoma — RIVERBOAT  

Cancer Survivor Clinical Trial

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

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03932786
Study type Observational
Source Vanderbilt-Ingram Cancer Center
Contact Vanderbilt-Ingram Service for Timely Access
Phone 800-811-8480
Email cip@vanderbilt.edu
Status Recruiting
Phase
Start date January 24, 2019
Completion date January 2031
View Details
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