Studying Health Outcomes After Treatment in Patients With Retinoblastoma

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Brief Title

Studying Health Outcomes After Treatment in Patients With Retinoblastoma

Official Title

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

Brief 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


      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 Type


Primary Outcome

Incidence of acute toxicity




Biospecimen collection

Study Arms / Comparison Groups

 Retrospective(biospecimens, vision assessment, questionnaires)


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

January 24, 2019

Completion Date

January 2026

Primary Completion Date

January 2025

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.




N/A - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers


Debra Friedman, MD, 800-811-8480, [email protected]

Location Countries


Location Countries


Administrative Informations



Organization ID


Secondary IDs


Responsible Party

Principal Investigator

Study Sponsor

Vanderbilt-Ingram Cancer Center


 National Cancer Institute (NCI)

Study Sponsor

Debra Friedman, MD, Principal Investigator, Vanderbilt Medical Center

Verification Date

April 2022