Pediatric Germ Cell Tumors: Outcomes, Genomics and Epigenetics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,151
- 试验地点
- 1
- 主要终点
- Somatic Mutations
研究概览
简要总结
A Non-Therapeutic Study that aims to establish a cohort of GCT survivors to understand short term and long-term adverse effects of treatment and to conduct molecular analyses to improve risk stratification.
详细描述
PRIMARY OBJECTIVES:
I. Establish a survivorship cohort for pediatric and adolescent GCT comprised of participants from AEPI10N1 and APEC14B1 to assess short term and long-term adverse events associated with GCT treatment.
II. Compare somatic variation by tumor histology to identify molecular signatures that improve prognostic risk stratification.
III. Identify methylation patterns that predict poor clinical outcomes, including disease relapse and death.
OUTLINE:
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cases will be eligible for the study if they have a primary diagnosis of GCT including germinoma (ICCC code105 9060-9065), teratoma (9080-9084), embryonal carcinoma (9070-9072), yolk sac tumor (9071), choriocarcinoma (9100, 9103, 9104), and mixed GCT (9085, 9101, 9102, 9105) in all sites including the brain.
- •The patient must be enrolled on APEC14B1 with consent to future contact or enrolled in AEPI10N1 with consent for future contact (N=827). Patients enrolled in AEPI10N1 were recruited from ACCRN
- •All patients must be registered with COG by a North American member institution. Note: (history of) treatment on a COG therapeutic trial is not required.
- •Patients must be diagnosed at < 20 years of age at the time of GCT diagnosis. Study participants will be followed over time in the survivorship study so there is no maximum age for participation.
- •Participants must be able to complete study related documents in English or Spanish.
- •All patients and/or their parents or legal guardians must provide informed consent. Assent will be obtained for participants between the ages of 8-17 years.
- •All institutional, FDA, and NCI requirements for human studies must be met.
排除标准
- •Participants from AEPI10N1 who did not consent to future contact. Patients who do not meet the eligibility criteria described above or cannot complete study materials in English or Spanish
结局指标
主要结局
Somatic Mutations
时间窗: Up to 5 years
Compare somatic variation by tumor histology to identify molecular signatures that improve prognostic risk stratification. Somatic mutations will be identified by comparing tumor samples to normal samples. Risk stratification will be based on event free survival, defined as the time from diagnosis to relapse or death.
Methylation
时间窗: Up to 5 years
Compare the association between DNA methylation patterns and relapse or death. Mixed-effects regression models will be used to test for association between methylation beta values and poor outcomes. The outcome will be defined as a binary variable with a value of one if the patient experienced a relapse or death event and zero otherwise.
Ototoxicity
时间窗: Up to 5 years
Ototoxicity as determined by central review of end of therapy audiograms will serve as the primary outcome variable for analyses. Current ototoxicity will be assessed using an app-based hearing assessment. For the app-based audiometry assessment, unilateral hearing loss will be defined as at least one pure tone threshold greater than 25 decibels across at any one of the frequencies from 2,000 Hz- 8,000 Hz to align with the SIOP Boston guidelines, while bilateral hearing loss will be defined as a pure tone threshold \> 25 decibels in both ears at any one of the frequencies.
次要结局
未报告次要终点