Research Into Visual Endpoints and RB Health Outcomes After Treatment (RIVERBOAT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 11
- 主要终点
- Incidence of acute toxicity
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of acute toxicity
时间窗: Up to 1 year
Assess psycho-social outcomes utilizing questionnaires: BRIEF
时间窗: 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.
时间窗: Up to 1 year
Assess quality of life utilizing questionnaires: Pediatric Quality of Life
时间窗: Up to 2 years
Assess visual outcomes measured via parent report
时间窗: Up to 1 year
Assess quality of life utilizing questionnaires: BRIEF
时间窗: Up to 2 years
Assess psycho-social outcomes utilizing questionnaires: CBCL
时间窗: Up to 2 years
Estimate malignant neoplasm (SMN) risk .Measured through medical record abstraction,
时间窗: Up to 1 year
Assess visual outcomes measured via age appropriate visual acuity testing
时间窗: Up to 1 year
Assess quality of life utilizing questionnaires: Youth Self-Report
时间窗: Up to 2 years
Assess psycho-social outcomes utilizing questionnaires: Youth Self-Report
时间窗: Up to 2 years
Assess psycho-social outcomes utilizing questionnaires: Pediatric Quality of Life
时间窗: Up to 2 years
Assess quality of life utilizing questionnaires: CBCL
时间窗: Up to 2 years
Assess psycho-social outcomes utilizing questionnaires: BRIEF-P,
时间窗: Up to 2 years
Assess visual outcomes measured via vision questionnaires
时间窗: Up to 1 year
次要结局
未报告次要终点
研究者
Debra Friedman
Sponsor Investigator
Vanderbilt-Ingram Cancer Center