Actively Recruiting

All Genders
Healthy Volunteers
ID03932786

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

Led by Vanderbilt-Ingram Cancer Center · Updated on 2025-09-19

900

Participants Needed

11

Research Sites

52 weeks

Total Duration

On this page

Sponsors

V

Vanderbilt-Ingram Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying health outcomes in patients who have been treated for retinoblastoma, a type of eye cancer. The study aims to understand acute treatment side effects, the risk of developing new cancers, visual outcomes, and psychosocial and physical effects in survivors compared to healthy siblings and standard data. The trial also explores genetic factors influencing disease and treatment responses through a specially annotated biorepository of patient tissues and DNA samples. Participants join one of two groups based on their treatment timeline. The retrospective group includes patients treated between 2008 and 2018 who provide saliva samples at least six months after treatment, undergo vision assessments, and complete questionnaires. The prospective group includes patients treated between 2018 and 2023 who provide saliva and tissue samples, undergo vision assessments at enrollment and follow-up times, and complete questionnaires. Immediate family members with retinoblastoma or the RB1 gene mutation may also provide saliva samples. During the study, participants undergo vision tests, provide tissue and saliva samples, and complete psychosocial and quality-of-life questionnaires at various times up to two years after treatment. Researchers will analyze genetic information and monitor acute toxicity and long-term outcomes through medical records and assessments. The total duration of participation varies with follow-up visits occurring up to two years after treatment, allowing comprehensive monitoring of health and vision outcomes.

CONDITIONS

Brief Title

Studying Health Outcomes After Treatment in Patients With Retinoblastoma

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with unilateral or bilateral intraocular retinoblastoma
  • Diagnosis made between ages 0 and 17.99 years
  • Diagnosis date on or after January 1, 2008
  • Retrospective group patients must be at least 6 months post-treatment at study entry
  • Prospective group patients must not have started treatment yet
  • Ability to communicate in English, French, or Spanish
  • One sibling without retinoblastoma may be enrolled, preferably closest in age to the patient
  • Written informed consent obtained from patient or legal guardian
  • Compliance with all regulatory requirements for human studies
Not Eligible

You will not qualify if you...

  • Patients with diminished capacity to participate
  • Patients not meeting language communication requirements
  • Patients who have not reached 6 months post-treatment for retrospective group
  • Patients who have begun treatment for the prospective group
  • Failure to provide informed consent or comply with regulatory requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - At enrollment and up to 2 years after treatment

Participants undergo collection of saliva and tissue samples, vision assessments, and complete questionnaires depending on cohort assignment.

1 to 2 visits depending on cohort and timepoints (enrollment, 6 months, 18 months, and 2 years)

Long-term Monitoring

Duration - Up to 2 years after treatment

Participants are followed for up to 2 years post-treatment to assess visual outcomes, psychosocial and neurocognitive outcomes, and quality of life through questionnaires and vision assessments.

Follow-up visits at 6 months, 1 year, 18 months, and 2 years depending on cohort

Trial Site Locations

Total: 11 locations

1

Lurie Children's Hospital

Chicago, Illinois, United States, 60611

Actively Recruiting

2

University of Illinois, Chicago

Chicago, Illinois, United States, 60612

Actively Recruiting

3

University of Minnesoa

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

4

Washington School of Medicine at St. Louis

St Louis, Missouri, United States, 63110

Actively Recruiting

5

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

6

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

7

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

8

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

9

Texas Childeren's Hospital

Houston, Texas, United States, 77030

Actively Recruiting

10

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

11

The Hosptial for Sick Children

Toronto, Canada

Actively Recruiting

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Research Team

V

Vanderbilt-Ingram Service for Timely Access

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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