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临床试验/NCT02679950
NCT02679950已完成不适用

Understanding the Molecular and Genetic Differences Between GCT at the Time of the Initial Diagnosis and at Late Relapse

Nasser Hanna2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2015年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Nasser Hanna
入组人数
6
试验地点
2
主要终点
Compare genomic profiles of curable germ cell tumors with non curable germ cell tumors

研究概览

简要总结

The current proposal is a pilot study. The Investigators plan to use next generation genome sequencing (NGGS) to define the molecular and genetic profiles of 3 cases of germ cell tumor (GCT) (with a component of yolk sac tumor) at the time of the initial diagnosis and 3 cases of late relapse GCT's, which are characterized by yolk sac tumor (and AFP secreting) predominant disease.

Investigators seek to demonstrate the feasibility of obtaining tissue biopsies (either archived or new biopsy) and utilization of NGGS in studying the molecular and genetic relationships between GCT's (with a component of yolk sac tumor) at the time of diagnosis and GCT's at the time of late relapse. This study will also provide preliminary information on genetic alterations, which may be a hypothesis for generating another study.

详细描述

This study will examine two cohorts:

  1. The initial diagnosis only cohort will include 3 patients with GCT who meet the inclusion criteria and have adequate tissue samples available in storage at the Pathology Department. One prospective blood and one tissue sample will be collected from each patient in this cohort. Tissue samples will come from the orchiectomy or virgin retro-peritoneal lymph node dissection (RPLND) that was done at initial diagnosis.
  2. The late relapse cohort will include 3 patients with late relapse GCT who meet the inclusion criteria and have adequate tissue samples available in storage at the Pathology Department. One prospective blood and two tissue samples will be collected from each patient in this cohort. Tissue samples will come from the orchiectomy or virgin RPLND that was done at initial diagnosis and the other will come from the site of late relapse.

Patients in this cohort will have biopsies at the site of late relapse as part of their routine cancer treatment. No biopsies will be performed specifically for the purposes of this study. Tissue from the site of late relapse will also be requested from the Pathology Department.

One tube of blood will be collected from each subject during a routine clinical visit at baseline when a blood draw is already being done.

In summary, a total of 15 samples will be evaluated on this study. Consent for the use of tissue and blood collected for the purposes of this study will be obtained prior to any study procedures. Subjects who do not have adequate tissue samples available will be replaced.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Compare genomic profiles of curable germ cell tumors with non curable germ cell tumors

时间窗: 1 year

Collection of tissue and blood samples from 6 patients for genomic testing

次要结局

未报告次要终点

研究者

发起方
Nasser Hanna
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nasser Hanna

Associate Professor of Medicine

Indiana University

研究点 (2)

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