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临床试验/NCT02797600
NCT02797600已完成不适用

Community Awareness, Resources and Education (CARE II) Project: Project 1

Ohio State University Comprehensive Cancer Center1 个研究点 分布在 1 个国家目标入组 285 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
285
试验地点
1
主要终点
Genetic variations in TGFβ ligand and receptor genes and other cancer-associated genes.

研究概览

简要总结

The study hypothesis is that the increased incidence of cervical cancer observed in Appalachian women over their non-Appalachian counterparts is due in part to inherited and somatic alterations of key components of the Transforming Growth Factor β (TGFβ) signaling pathway.

详细描述

This project is a case control study that is designed to determine prevalence of inherited polymorphic and somatically acquired variants of key TGF-ß pathway components in a large cohort of Appalachian invasive cervical cancer (ICC) patients compared to healthy Appalachian women. It will be determined whether these genetic alterations contribute individually or in combination with other known environmental (Human Papillomavirus, Epstein-Barr Virus), behavioral (smoking), and social (stress, social networks) risk factors, to the increased susceptibility of Appalachian women to ICC development. Women will be recruited from several clinics and physician practices in West Virginia, Charleston and Appalachia Ohio and Kentucky. Participants will be women residing in these area who are 18 years and older, not pregnant, speak English, not cognitively impaired and able to provide informed consent. There will be three distinct types of women recruited into the study; 1. ARM 1 - previously treated for invasive cervical cancer; 2. ARM 2 - newly diagnosed with invasive cervical cancer; and 3. healthy controls - without a diagnosis of cervical cancer.

研究设计

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

入排标准

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

入选标准

  • 18 years and older
  • Patients previously or newly diagnosed with invasive cervical cancer
  • healthy women without a diagnosis of any type of cancer
  • English speaking
  • Able to provide informed consent, biological and questionnaire data.

排除标准

  • Pregnant women

结局指标

主要结局

Genetic variations in TGFβ ligand and receptor genes and other cancer-associated genes.

时间窗: Day 1

The number of participants with genetic variations in TGFβ ligand and receptor genes and other cancer-associated genes with known single nucleotide polymorphisms as determined by direct sequencing and SNP PCR analyses

次要结局

  • Environmental, behavioral and socioeconomic risk factors.(Day 1)

研究者

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

Electra Paskett

Principal Investigator

Ohio State University Comprehensive Cancer Center

研究点 (1)

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