Studying Health Outcomes After Treatment in Patients With Retinoblastoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen collection, Vision assessment, Questionnaire administration, Quality of life assessment.
- Who it may be relevant to
- Registry conditions: Retinoblastoma, Cancer Survivor, Biological Sibling, Intraocular Retinoblastoma. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Research Into Visual Endpoints and RB Health Outcomes After Treatment (RIVERBOAT)
Overview
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.
Interventions
- 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
Primary outcome measures
- Incidence of acute toxicity [Time frame: Up to 1 year]
- Estimate malignant neoplasm (SMN) risk .Measured through medical record abstraction, [Time frame: Up to 1 year]
- Assess visual outcomes measured via age appropriate visual acuity testing [Time frame: Up to 1 year]
- Assess psycho-social outcomes utilizing questionnaires: BRIEF [Time frame: Up to 2 years]
- Genes will be tested to examine the role they play in Retinoblastoma. This will be done via whole-exome sequencing and whole RB1 Gene examination. [Time frame: Up to 1 year]
- Assess quality of life utilizing questionnaires: BRIEF [Time frame: Up to 2 years]
- Assess quality of life utilizing questionnaires: CBCL [Time frame: Up to 2 years]
- Assess quality of life utilizing questionnaires: Youth Self-Report [Time frame: Up to 2 years]
- Assess quality of life utilizing questionnaires: Pediatric Quality of Life [Time frame: Up to 2 years]
- Assess visual outcomes measured via parent report [Time frame: Up to 1 year]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 10 centers
- Lurie Children's Hospital — Chicago
- University of Illinois, Chicago — Chicago
- University of Minnesoa — Minneapolis
- Washington School of Medicine at St. Louis — St Louis
- Cincinnati Children's Hospital Medical Center — Cincinnati
- Children's Hospital of Philadelphia — Philadelphia
- Vanderbilt-Ingram Cancer Center — Nashville
- MD Anderson Cancer Center — Houston
- … and 2 more centers
Canada · 1 center
- The Hosptial for Sick Children — Toronto
Identifiers
NCT: NCT03932786 · VICC PED 1878 · R01CA225005 · NCI-2019-00635