Molecular Epidemiology of Pediatric Germ Cell Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 932
- 试验地点
- 1
- 主要终点
- Pediatric GCT associated with genetic susceptibility
研究概览
简要总结
This research trial studies deoxyribonucleic acid (DNA) samples from younger patients with germ cell tumor and their parents or siblings. Studying samples of tumor tissue and saliva from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
详细描述
OBJECTIVES:
I. To evaluate associations between genetic variation and pediatric germ cell tumor (GCT) using a case-parent triad design to identify variants in four genes, KITLG, SPRY4, BAK1, and DMRT1, associated with pediatric GCT.
II. To evaluate associations between genetic variation and pediatric GCT using a case-parent triad design to include targeted genotyping of single nucleotide polymorphisms (SNPs) in selected key pathways essential for normal in utero germ cell development, specifically genes involved in survival of germ cells during migration, apoptosis, and cell cycle control.
III. To explore inter- and intratumoral heterogeneity in DNA methylation by tumor histology.
OUTLINE: This is a multicenter study.
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is enrolled on COG-ACCRN07
- •The patient has a primary diagnosis of germ cell tumor (GCT) including germinoma (ICCC 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 and central nervous system and registered with Children's Oncology Group (COG) by a North American member institution
- •The patient must be diagnosed with a germ cell tumor between July 1, 2008 and December 31, 2015
- •The patient must be < 20 years of age at the time of diagnosis
- •The patient must have at least one biological parent alive and willing to participate
- •In the event that one case parent cannot contribute DNA, a case sibling, defined as the biological brother or sister of the study subject, may donate instead
- •All questionnaire respondents must understand English or Spanish
- •Concomitant treatment on a therapeutic trial is not required
排除标准
- 未提供
结局指标
主要结局
Pediatric GCT associated with genetic susceptibility
时间窗: Up to 5 years
Will be modeled using a Poisson regression. A likelihood ratio test determines the statistical significance.
次要结局
- List of genes that distinguish between the three most common histologic subtypes of pediatric GCT: yolk sac tumor, teratoma, and germinoma(Up to 5 years)
- Validation of array results by pyrosequencing(Up to 5 years)