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Completed

NCT Number: NCT02113514

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

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.

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Key information

Conditions

Cervical Abnormality

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Michigan, Ann Arbor, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Social/environmental variables of access to screening were analyzed to see if they contribute to increased risk of developing abnormalities among Appalachian women.

    Time frame: Participant completed all activites on the 1 day of the clinic visit.

    On the day of study enrollment, survey data and specimens were obtained from the participants.

Secondary outcomes

  1. Behavioral variables of age of onset of sexual intercourse, number of partners, male partner factors, multiparity, oral contraceptive use, and smoking were analyzed to see if they contribute to the increased risk of developing abnormalities.

    Time frame: Participant completed all activites on the 1 day of the clinic visit.

    On the day of study enrollment, survey data and specimens were obtained from the participants.

  2. Biological variables of HPV status, HPV type, HPV variants, HPV viral load, and serology to HPV were analyzed to see if they contribute to the increased risk of developing cervical abnormalities among Appalachian women.

    Time frame: Participant completed all activites on the 1 day of the clinic visit.

    On the day of study enrollment, survey data and specimens were obtained from the participants.

  3. Combinations of social, behavioral, and biological determinants were analyzed to see which contribute to the increased risk of developing cervical abnormalities among Appalachian women.

    Time frame: Participant completed all activites on the 1 day of the clinic visit.

    On the day of study enrollment, survey data and specimens were obtained from the participants.

Other outcomes

  1. Factors that impede follow-up and treatment of abnormal or suspicious Pap smear findings were identified.

    Time frame: Participant completed all activites on the 1 day of the clinic visit.

    On the day of study enrollment, survey data and specimens were obtained from the participants.

  2. New molecular markers related to cervical cancer were explored.

    Time frame: Participant completed all activites on the 1 day of the clinic visit.

    On the day of study enrollment, survey data and specimens were obtained from the participants.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • University of Michigan

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Apr 14, 2014
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.