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临床试验/NCT03959800
NCT03959800招募中不适用

Genetic and Molecular Basis of Pediatric Liver Cancer

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2015年6月22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
1,600
试验地点
2
主要终点
Gene sequencing

研究概览

简要总结

The purpose of this retrospective and prospective project is to understand the molecular and genetic basis of liver cancer of childhood. Understanding the molecular and genetic bases of liver cancers can offer a better classification based on tumor biology, mechanisms and predisposition.

详细描述

Pediatric liver cancers are rare, affecting at times no more than 1 in one million population. Understanding the molecular basis of these cancers is important in order to develop more accurate diagnoses and more effective treatments. Current classifications of these cancers are based on how these cancers look on diagnostic studies such as radiologic imaging or under the microscope. Such a classification system does not explain why a particular cancer has a different outcome from what is considered "usual" for that particular cancer. Nor does such a classification system explain why two different classes of cancers behave the same way. Understanding the genetic bases of liver cancers can offer a better classification based on tumor biology, mechanisms and predisposition.

To achieve these goals, large numbers of such cancer patients or affected tissue must be collected. This is not possible in any single institution, or any single country. The current project will collect biological samples such as residual tumor tissue, saliva, or blood from affected patients and their biological parents and families, along with clinical information about the cancer. These biological samples will be used to study the genes and how these genes work in tumor tissue and in non-tumor tissue. The results of this study will permit childhood liver cancers to be categorized on the basis of common defects in genes and their function.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
0 Years 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Prior or current treatment for a childhood liver tumor, malignant or benign, at age <21 years.
  • Biological parents and siblings of eligible children.

排除标准

  • No prior or current treatment for a childhood liver tumor.
  • Non-biological parents, legal guardians, or non-biological siblings of eligible children.

结局指标

主要结局

Gene sequencing

时间窗: Recurrence free survival at 2 years

DNA sequence variants

Status of genome-wide chromatin accessibility

时间窗: Duration of active chemotherapy to two years after surgical treatment

chromatin accessibility

Gene expression analysis

时间窗: Recurrence free survival at 2 years

Differentially expressed genes

Tumor infiltrating cells which express immune checkpoints

时间窗: Duration of active chemotherapy to two years after surgical treatment

differentially enriched immune cells

Epigenetic change

时间窗: Duration of active chemotherapy to two years after surgical treatment

Differential methylation

次要结局

  • Response to chemotherapy(Duration of active chemotherapy to two years after surgical treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rakesh Sindhi

Professor of Surgery

University of Pittsburgh

研究点 (2)

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Molecular Basis of Pediatric Liver Cancer | 临床试验