Community Awareness, Resources and Education (CARE I): Project 3

The Ohio State University

Status: Completed

Conditions: Cervical Abnormality

Study type: Observational

Funder types: Other

Identifiers

NCT02113514

OSU-0490

Details and patient eligibility

About

Community Awareness, Resources and Education (CARE) Project - Project 3 will determine if Appalachian women have unique risk factors for an abnormal Pap smear that might contribute to the increased risk of cervical abnormalities, specifically cancer, in their communities.

Full description

The aim of CARE: Project 3 is to determine the social, behavioral, and biological variables that might contribute to increased risks of an abnormal Pap smear in Appalachian women in Ohio. To accomplish these aims, a case-control study was proposed. Women age 18 and older with an intact cervix, not pregnant, and no current or past history of invasive cervical cancer are recruited at the time of their scheduled Pap smear from clinics/physician practices in Appalachian region of Ohio. Women receiving Pap tests at participating medical clinics/physician practices are recruited for a case control epidemiologic study assessing HPV prevalence and its impact on cervical intraepithelial neoplasia (CIN). Cervical mucus will be collected for Human Papillomavirus (HPV) assays and stored for potential other assays related to HPV. Serum will be drawn for HPV serology and stored for future analysis. Controls are defined as women with a normal Pap smear. Cases are defined as women with abnormal Pap smear (from atypical squamous cells of uncertain significance (ASCUS) to cancer.

Enrollment: 2,394 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female
• 18 years or older
• Able to give informed consent
• Intact cervix
• No prior history of invasive cervical cancer
• English speaking
• Willing to have biological specimens stored for future studies
• Resident of Appalachian Ohio

Exclusion criteria

• Pregnant
• Medical or psychiatric illness that precludes research project requirements, ability to give informed consent, or protocol compliance.
• Smokers (will be contacted by study team to see if they are eligible/willing to participate in CARE: Project 2

Trial design

2,394 participants in 2 patient groups

Normal Pap smear

Description:

Women with normal pap test.

Abnormal Pap smear

Description:

Women with abnormal pap test.