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Studying Health Outcomes After Treatment in Patients With Retinoblastoma (RIVERBOAT)

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ClinicalTrials.gov Identifier: NCT03932786
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : April 22, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Debra Friedman, Vanderbilt-Ingram Cancer Center

Study Description
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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

Condition or disease Intervention/treatment
Retinoblastoma Cancer Survivor Biological Sibling Intraocular Retinoblastoma Unilateral Retinoblastoma Procedure: Biospecimen collection Other: Vision assessment Other: Questionnaire administration Other: Quality of life assessment Other: Laboratory Biomarker Analysis

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Research Into Visual Endpoints and RB Health Outcomes After Treatment (RIVERBOAT)
Actual Study Start Date : January 24, 2019
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Retrospective(biospecimens, vision assessment, questionnaires) 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
Prospective (biospecimens, vision assessment, questionnaires) 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


Outcome Measures
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Primary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Tissue, saliva

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Retrospective patients (those treated between 2008 and 2018) identified by each site at the start of the study period and prospective patients (those treated between 2018 and 2023) identified at the time of diagnosis by each site during the study period with unilateral or bilateral intraocular retinoblastoma
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03932786


Contacts
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Contact: Vanderbilt-Ingram Service for Timely Access 800-811-8480 cip@vanderbilt.edu

Locations
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United States, Illinois
Lurie Children's Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Monica Newmark       mnewmark@luriechildrens.org   
Principal Investigator: Joanna Weinstein, MD         
University of Illinois, Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Kristen kitsch       kitsc@uic.edu   
Principal Investigator: Mary Lou Schmidt, MD         
United States, Minnesota
University of Minnesoa Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Kendra Pallin       palli007@umn.edu   
Principal Investigator: Joseph Neglia, MD         
United States, Missouri
Washington School of Medicine at St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Kara Sauerburger       sauerburgerk@wustl.edu   
Principal Investigator: Robert Hayashi, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Amanda Pfeiffer       amanda.pfeiffer@cchmc.org   
Principal Investigator: Rajaram Nagarajan, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Stephen Markham       markhams@chop.edu   
Principal Investigator: Amish Shah, MD, PhD         
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Vanderbilt-Ingram Service for Timely Access    800-811-8480      
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Theresa Honey       TAHoney@mdanderson.org   
Principal Investigator: Anna Herzog, MD         
Texas Childeren's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Najeeba Ali       nmali@texaschildrens.org   
Principal Investigator: Murali Chintagumpala, MD         
United States, Wisconsin
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Veronica Seher       vseher@mcw.edu   
Principal Investigator: Cindy Schwartz, MD         
Canada
The Hosptial for Sick Children Recruiting
Toronto, Canada
Contact: Roxanna Noronha       roxanna.noronha@sickkids.ca   
Principal Investigator: Helen Dimaras, MD         
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Debra Friedman, MD Vanderbilt Medical Center
More Information
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Responsible Party: Debra Friedman, Sponsor Investigator, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT03932786    
Other Study ID Numbers: VICC PED 1878
NCI-2019-00635 ( Registry Identifier: NCI, Clinical Trials Reporting Program )
1R01CA225005-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: April 22, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Retinoblastoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
 Neoplasms, Nerve Tissue
Retinal Neoplasms
Eye Neoplasms
Neoplasms by Site
Eye Diseases, Hereditary
Eye Diseases
Retinal Diseases