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临床试验/NCT00992303
NCT00992303招募中不适用

Tissue Procurement and Outcome Collection for Radiotherapy Treated Patients and Healthy Participants

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2009年9月1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
10,000
试验地点
2
主要终点
Maintenance a Tissue Resource and Registry/Database

研究概览

简要总结

RATIONALE: Collecting and storing samples of tissue from patients with cancer to test in the laboratory may help the study of cancer in the future.

PURPOSE: This research study is collecting tissue samples from patients with cancer undergoing radiation therapy. Healthy participants will also be allowed on the trial so their samples can be used in comparison to patients with malignancy

详细描述

OBJECTIVES:

Primary

  • To maintain and create a University of Texas Southwestern Medical Center (UTSW) Radiation Oncology Tissue Resource and Registry/Database that will be used to explore genetic variations contributing to clinical outcomes through tissue analysis and outcome correlation. Tissue will be stored by the UTSTR and the database managed by Radiation Oncology.

Secondary

  • To document disease outcome (local recurrence, distant metastasis, overall survival) by treatment regimen and disease site.
  • To document toxicity by treatment regimen and disease site.
  • To establish a prospective registry/database consisting of patient demographics and outcomes to be used for future research.

研究设计

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

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

  • DISEASE CHARACTERISTICS:
  • Pathologically-proven diagnosis of malignancy
  • Planning treatment with radiation therapy
  • PATIENT CHARACTERISTICS:
  • Able to perform follow-up visits
  • Is a patient of the University of Texas Southwestern Medical Center physicians
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • Participation in other clinical trials is allowed
  • Other prior or concurrent therapy for cancer, such as surgery and/or chemotherapy, is allowed.
  • Criteria for eligibility:
  • Able to provide written informed consent
  • Age greater than 18 years old
  • Males and Females are eligible
  • Any ethnicity is eligible
  • Criteria for ineligibility:
  • Patients not available for follow-up/future contact

排除标准

  • 未提供

结局指标

主要结局

Maintenance a Tissue Resource and Registry/Database

时间窗: 10 years

Maintenance and creation of a University of Texas Southwestern Medical Center (UTSW) Radiation Oncology Tissue Resource and Registry/Database

次要结局

  • Local recurrence(5 years)
  • Distant metastasis(5 years)
  • Toxicity by treatment regimen(1 year)
  • Overall survival(5 years)
  • Establishment of a prospective registry/database(10 years)

研究者

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

Robert Timmerman

Professor

University of Texas Southwestern Medical Center

研究点 (2)

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