Community Awareness, Resources and Education (CARE II) Project: Project 1
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
- 是
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
Electra Paskett
Principal Investigator
Ohio State University Comprehensive Cancer Center
