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NCT Number: NCT03932786

Studying Health Outcomes After Treatment in Patients With Retinoblastoma

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

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Key information

Conditions

Retinoblastoma Biological Sibling Cancer Survivor Eye Diseases Eye Diseases, Hereditary Eye Neoplasms Intraocular Retinoblastoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Retinal Diseases Retinal Neoplasms Unilateral Retinoblastoma

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hosptial for Sick Children, Toronto, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Biospecimen Collection

Procedure

Collection of tissue and saliva samples

Vision assessment

Other

Undergo vision assessment

Questionnaire Administration

Other

Complete questionnaires

Quality of Life Assessment

Other

Complete questionnaires

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Incidence of acute toxicity

    Time frame: Up to 1 year

  2. Estimate malignant neoplasm (SMN) risk .Measured through medical record abstraction,

    Time frame: Up to 1 year

  3. Assess visual outcomes measured via age appropriate visual acuity testing

    Time frame: Up to 1 year

  4. Assess psycho-social outcomes utilizing questionnaires: BRIEF

    Time frame: Up to 2 years

  5. 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

  6. Assess quality of life utilizing questionnaires: BRIEF

    Time frame: Up to 2 years

  7. Assess quality of life utilizing questionnaires: CBCL

    Time frame: Up to 2 years

  8. Assess quality of life utilizing questionnaires: Youth Self-Report

    Time frame: Up to 2 years

  9. Assess quality of life utilizing questionnaires: Pediatric Quality of Life

    Time frame: Up to 2 years

  10. Assess visual outcomes measured via parent report

    Time frame: Up to 1 year

  11. Assess visual outcomes measured via vision questionnaires

    Time frame: Up to 1 year

  12. Assess psycho-social outcomes utilizing questionnaires: BRIEF-P,

    Time frame: Up to 2 years

  13. Assess psycho-social outcomes utilizing questionnaires: CBCL

    Time frame: Up to 2 years

  14. Assess psycho-social outcomes utilizing questionnaires: Youth Self-Report

    Time frame: Up to 2 years

  15. Assess psycho-social outcomes utilizing questionnaires: Pediatric Quality of Life

    Time frame: Up to 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Vanderbilt-Ingram Service for Timely Access

CONTACT

[email protected]

800-811-8480

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: RIVERBOAT

Important dates

Study start
2019
Primary completion
2030
Study completion
2031
First posted
May 1, 2019
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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