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

NCT ID: NCT02113514

Last Updated: 2015-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2394 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-05-31

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cervical Abnormality

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal Pap smear

Women with normal pap test.

No interventions assigned to this group

Abnormal Pap smear

Women with abnormal pap test.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Electra Paskett

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Electra D. Paskett, PhD

Role: PRINCIPAL_INVESTIGATOR

The Ohio State University Center for Population Health and Health Disparities

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

The Ohio State University

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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Patel DA, Rozek LS, Colacino JA, Van Zomeren-Dohm A, Ruffin MT, Unger ER, Dolinoy DC, Swan DC, Onyekwuluje J, DeGraffinreid CR, Paskett ED. Patterns of cellular and HPV 16 methylation as biomarkers for cervical neoplasia. J Virol Methods. 2012 Sep;184(1-2):84-92. doi: 10.1016/j.jviromet.2012.05.022. Epub 2012 Jun 1.

Reference Type BACKGROUND
PMID: 22664184 (View on PubMed)

Ruffin MT 4th, Hade EM, Gorsline MR, DeGraffinreid CR, Katz ML, Kobrin SC, Paskett ED. Human papillomavirus vaccine knowledge and hypothetical acceptance among women in Appalachia Ohio. Vaccine. 2012 Aug 3;30(36):5349-57. doi: 10.1016/j.vaccine.2012.06.034. Epub 2012 Jun 27.

Reference Type RESULT
PMID: 22749839 (View on PubMed)

Reiter PL, Katz ML, Ruffin MT, Hade EM, DeGraffenreid CR, Patel DA, Paskett ED, Unger ER. HPV prevalence among women from Appalachia: results from the CARE project. PLoS One. 2013 Aug 30;8(8):e74276. doi: 10.1371/journal.pone.0074276. eCollection 2013.

Reference Type RESULT
PMID: 24023700 (View on PubMed)

Related Links

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Other Identifiers

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OSU-0490

Identifier Type: -

Identifier Source: org_study_id

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