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

The Ohio State University

Status: Completed

Conditions: Cervical Cancer

Treatments: Behavioral: Questionnaires; Other: Biological Samples

Study type: Observational

Funder types: Other

Identifiers

NCT02797600

OSU-10095

Details and patient eligibility

About

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.

Full 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.

Enrollment: 285 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Pregnant women

Trial design

285 participants in 3 patient groups

ARM I

Description:

Woman residing in Appalachian counties who have prevalent invasive cervical cancer. Invasive cervical cancer cases participants will include women previously and currently treated for ICC during the past 10 years. Questionnaires will be used to obtain self-reported demographic, behavioral, social, family and medical history, and quality of life data. Biological samples will be collected during a scheduled visit with the research staff.

Treatment:

Other: Biological Samples

Behavioral: Questionnaires

ARM II

Description:

Woman residing in Appalachian counties who are newly diagnosed with invasive cervical cancer(ICC). Newly diagnosed with ICC, and currently being treated for ICC. Questionnaires will be used to obtain Questionnaires will be used to obtain self-reported demographic, behavioral, social, family and medical history, and quality of life data. All biological samples will be collected during a scheduled clinic visit.

Treatment:

Other: Biological Samples

Behavioral: Questionnaires

ARM III

Description:

Healthy controls (women without a diagnosis of any type of cancer. Healthy controls will be women who are coming into one of the participating clinic or physician practice for a routine Pap test. Questionnaires will be used to obtain Questionnaires will be used to obtain self-reported demographic, behavioral, social, family and medical history, and quality of life data. All biological samples will be collected at the time of the clinical Pap smear.

Treatment:

Other: Biological Samples

Behavioral: Questionnaires