Cervical AbnormalityNCT02113514
Community Awareness, Resources and Education (CARE I): Project 3
An observational study of Cervical Abnormality, run by Ohio State University Comprehensive Cancer Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Abnormality
- How many people
- 2,394 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2005to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Woman 18 years or older that are nonpregnant with intact cervix and no cervical cancer who present for a Pap smear. Must be residents of an Appalacian Ohio county.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
The Ohio State University
Columbus, Ohio, 43201
About this study
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.
Read the detailed 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.
- Conditions
- Cervical Abnormality
- Keywords
- Appalachian, abnormal pap test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal Pap smear | Women with normal pap test. | |
| Abnormal Pap smear | Women with abnormal pap test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social/environmental variables of access to screening were analyzed to see if they contribute to increased risk of developing abnormalities among Appalachian women.
On the day of study enrollment, survey data and specimens were obtained from the participants.
Measured: Participant completed all activites on the 1 day of the clinic visit.
Secondary outcomes (3)
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.
On the day of study enrollment, survey data and specimens were obtained from the participants.
Measured: Participant completed all activites on the 1 day of the clinic visit.
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.
On the day of study enrollment, survey data and specimens were obtained from the participants.
Measured: Participant completed all activites on the 1 day of the clinic visit.
Combinations of social, behavioral, and biological determinants were analyzed to see which contribute to the increased risk of developing cervical abnormalities among Appalachian women.
On the day of study enrollment, survey data and specimens were obtained from the participants.
Measured: Participant completed all activites on the 1 day of the clinic visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startMay 2005
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervical AbnormalityStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,394 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Principal investigator, Electra Paskett, Ohio State University Comprehensive Cancer Center
- Investigators
- Electra D. Paskett, PhD, Principal investigator, The Ohio State University Center for Population Health and Health Disparities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113514
- Sponsor's protocol ID
- OSU-0490
- Status last verified
- Apr 2015
- First submitted
- 10 Apr 2014
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22664184Ruffin 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.
PubMed 22749839Reiter 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.
PubMed 24023700
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Awareness, Resources and Education (CARE I): Project 3
- ClinicalTrials.gov ID
- NCT02113514
- Acronym / sponsor ID
- OSU-0490
- Conditions
- Cervical Abnormality
- Keywords
- Appalachian, abnormal pap test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,394 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- May 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 14 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Pap smear | – | –Women with normal pap test. |
| Abnormal Pap smear | – | –Women with abnormal pap test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Woman 18 years or older that are nonpregnant with intact cervix and no cervical cancer who present for a Pap smear. Must be residents of an Appalacian Ohio county.
Key inclusion criteria (8 listed)
- Female
- 18 years or older
- Able to give informed consent
- Intact cervix
- No prior history of invasive cervical cancer
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Background: PubMed 22664184Patel 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.
- Results publication: PubMed 22749839Ruffin 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.
- Results publication: PubMed 24023700Reiter 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.
- JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Electra D. Paskett, PhD principal investigator
The Ohio State University Center for Population Health and Health Disparities
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Abnormality, run by Ohio State University Comprehensive Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02113514, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.