NCT02797600

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 285 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Questionnaires	Questionnaires will be used to obtain self-reported demographic, behavioral, social, family and medical history, and quality of life data. The questions are standardized and taken from either nationally recognized surveys, CARE I surveys, or represent validated survey items.
OTHER	Biological Samples	All biological samples will be collected at the time of the clinical Pap smear for the controls, and will be collected for the Arm 2 (newly diagnosed) during a scheduled clinic visit. For those individuals in Arm 1, biological samples will be collected during a scheduled visit with the research staff.

Timeline

• Start date: 2011-06-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2016-06-13
• Last updated: 2024-04-02

Locations

1 site across 1 country: United States