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临床试验/NCT00776178
NCT00776178已完成不适用

Feasibility Study: Follow-Up of Bladder Cancer Patients From the New England Study of Environment and Health

National Cancer Institute (NCI)1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2008年10月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
1
主要终点
There is no intervention. We are looking at survival.

研究概览

简要总结

Background:

  • Bladder cancer often recurs after treatment and patient survival varies greatly.
  • More knowledge is needed about factors that can help identify patients who are at greater risk of disease recurrence and progression to minimize the need for screening and to help guide treatment.
  • The New England Study of Environment and Health (NESEH), conducted by the departments of health in Maine, New Hampshire and Vermont, the Dartmouth Medical School and the NIH, examined the relationship between health and environmental factors such as smoking, diet and water quality in New England. This study provides an opportunity to learn more about patients with bladder cancer.
  • Before launching a full-scale follow-up study on bladder cancer, it is necessary to determine the feasibility of obtaining needed follow-up information from patients enrolled in the NESEH.

Objectives:

-To determine the completeness and quality of information about treatment, recurrence, and progression that can be obtained for patients from their medical records.

Eligibility:

-Participants from the NESEH study who are residents of Maine and who were diagnosed with bladder cancer between 2001 and 2003.

Design:

  • Determine the vital status of NESEH bladder cancer patients.
  • Select a sample of 40 living and 18 deceased patients.
  • Interview patients or their next of kin by telephone for about 30 to 45 minutes to update exposure information, obtain names and addresses of all hospitals and physicians they have seen since diagnosis, and obtain authorization to access medical records.
  • Obtain and abstract medical records.

详细描述

Background:

  • Bladder cancer is a highly recurrent disease with substantial variability in survival.
  • Patients currently undergo repeated cystoscopy for many years after diagnosis.
  • There is a need to identify prognostic markers of recurrence and progression to minimize the need for routine screening and to identify patients who should be treated more aggressively.
  • The New England Study of Environment and Health (NESEH), a population-based case control study of 1,213 patients in Maine (ME), Vermont (VT), and New Hampshire (NH), provides an excellent opportunity study the clinical, host-genetic, and environmental determinants of prognosis.
  • Before launching a full-scale follow-up study, we need to determine the feasibility of following a population-based case series and of obtaining patient-related (vital status, exposures) and tumor-related (recurrence, progression, pathology) information.

Objectives:

To determine:

  • The completeness and quality of information that can be obtained for each patient. The most important issue is the extent to which medical records from private physicians will be needed, and whether private physicians are cooperative.
  • Our ability to identify next-of-kin (NOK) of deceased patients.
  • The proportion of patients (and NOK) that we can contact and enroll.
  • The ability of NOK to provide information on exposures.

研究设计

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

入排标准

年龄范围
30 Years 至 79 Years(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

There is no intervention. We are looking at survival.

时间窗: September 30, 2015

Overall Survival

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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