Studying Health Outcomes After Treatment in Patients With Retinoblastoma
- Conditions
- Cancer SurvivorBiological SiblingRetinoblastomaIntraocular RetinoblastomaUnilateral Retinoblastoma
- Interventions
- Procedure: Biospecimen collectionOther: Vision assessmentOther: Questionnaire administrationOther: Quality of life assessmentOther: Laboratory Biomarker Analysis
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 900
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prospective (biospecimens, vision assessment, questionnaires) Biospecimen collection - Prospective (biospecimens, vision assessment, questionnaires) Questionnaire administration - Retrospective(biospecimens, vision assessment, questionnaires) Biospecimen collection - Retrospective(biospecimens, vision assessment, questionnaires) Questionnaire administration - Retrospective(biospecimens, vision assessment, questionnaires) Quality of life assessment - Retrospective(biospecimens, vision assessment, questionnaires) Vision assessment - Retrospective(biospecimens, vision assessment, questionnaires) Laboratory Biomarker Analysis - Prospective (biospecimens, vision assessment, questionnaires) Quality of life assessment - Prospective (biospecimens, vision assessment, questionnaires) Vision assessment - Prospective (biospecimens, vision assessment, questionnaires) Laboratory Biomarker Analysis -
- Primary Outcome Measures
Name Time Method Assess quality of life utilizing questionnaires: CBCL Up to 2 years Assess psycho-social outcomes utilizing questionnaires: BRIEF-P, 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 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 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 visual outcomes measured via vision questionnaires Up to 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
University of Minnesoa
🇺🇸Minneapolis, Minnesota, United States
Texas Childeren's Hospital
🇺🇸Houston, Texas, United States
Washington School of Medicine at St. Louis
🇺🇸Saint Louis, Missouri, United States
Lurie Children's Hospital
🇺🇸Chicago, Illinois, United States
The Hosptial for Sick Children
🇨🇦Toronto, Canada
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
University of Illinois, Chicago
🇺🇸Chicago, Illinois, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Children's Hospital of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States