Studying Health Outcomes After Treatment in Patients With Retinoblastoma

Recruiting

• Conditions: Cancer Survivor; Biological Sibling; Retinoblastoma; Intraocular Retinoblastoma; Unilateral Retinoblastoma

• Registration Number: NCT03932786
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

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

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 Timeline

• Study Start: 2019-01-24
• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-04-27
• Study First Posted: 2019-05-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Primary Completion: 2030-01
• Study Completion: 2031-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of acute toxicity	Up to 1 year
Assess psycho-social outcomes utilizing questionnaires: BRIEF	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.	Up to 1 year
Assess quality of life utilizing questionnaires: Pediatric Quality of Life	Up to 2 years
Assess visual outcomes measured via parent report	Up to 1 year
Assess quality of life utilizing questionnaires: BRIEF	Up to 2 years
Assess psycho-social outcomes utilizing questionnaires: CBCL	Up to 2 years
Estimate malignant neoplasm (SMN) risk .Measured through medical record abstraction,	Up to 1 year
Assess visual outcomes measured via age appropriate visual acuity testing	Up to 1 year
Assess quality of life utilizing questionnaires: Youth Self-Report	Up to 2 years
Assess psycho-social outcomes utilizing questionnaires: Youth Self-Report	Up to 2 years
Assess psycho-social outcomes utilizing questionnaires: Pediatric Quality of Life	Up to 2 years
Assess quality of life utilizing questionnaires: CBCL	Up to 2 years
Assess visual outcomes measured via vision questionnaires	Up to 1 year
Assess psycho-social outcomes utilizing questionnaires: BRIEF-P,	Up to 2 years

Trial Locations

Locations (11)

Lurie Children's Hospital; 🇺🇸 Chicago, Illinois, United States

University of Illinois, Chicago; 🇺🇸 Chicago, Illinois, United States

University of Minnesoa; 🇺🇸 Minneapolis, Minnesota, United States

Washington School of Medicine at St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Texas Childeren's Hospital; 🇺🇸 Houston, Texas, United States

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

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