跳至主要内容
临床试验/NCT06054295
NCT06054295招募中不适用

Somatic Mosaicism in Twins Discordant for Childhood Cancer: a Pilot Study

Children's Oncology Group1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年6月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Compare the prevalence of somatic mosaicism in classic cancer-associated genes in monozygotic (MZ) twins discordant for childhood brain tumors.

研究概览

简要总结

Somatic mosaicism in cancer associated genes is one potential explanation for discordance in childhood cancer that has not been fully explored to date. This pilot study will focus on twins with central nervous system (CNS) tumors who are identified through the Children's Oncology Group's Project: EveryChild (PEC) registry or volunteer.

详细描述

PRIMARY OBJECTIVES:

I. To conduct a descriptive study of same sex twins (MZ and DZ) discordant for childhood CNS tumors identified through the Children's Oncology Group Project:EveryChild registry.

II. To compare the prevalence of somatic mosaicism in classic cancer-associated genes in monozygotic (MZ) twins discordant for childhood brain tumors. In our pilot study, we will sequence blood and saliva DNA samples from 25 MZ twin pairs using a panel of 94 known cancer associated genes.

SECONDARY OBJECTIVES:

I. To compare the profile of mutations detected in DNA extracted from pre- and post-treatment blood samples from a subset of CNS tumor patients. The purpose of this aim is to ensure that differences in somatic mosaicism detected in twin pairs are not caused by cancer therapy.

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 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Newly diagnosed patient with CNS tumor or have recurrent disease and enrolled on APEC14B
  • Patient must have same sex twin. Note: (history of) treatment on a COG therapeutic trial is not required.
  • Patients must be diagnosed at < 19 years of age at the time of diagnosis.
  • A family is eligible to participate if the twin with the CNS tumor is deceased but has a blood sample banked through APEC14B
  • 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

  • 未提供

结局指标

主要结局

Compare the prevalence of somatic mosaicism in classic cancer-associated genes in monozygotic (MZ) twins discordant for childhood brain tumors.

时间窗: Up to 18 months

Sequence blood and saliva DNA samples from 25 MZ twin pairs using a panel of 94 known cancer associated genes.

次要结局

  • Compare the profile of mutations detected in DNA extracted from pre- and post-treatment blood samples from a subset of CNS tumor patients.(Up to 18 months)

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验