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Cervical Cancer Screening Project Part C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01575444
Recruitment Status : Terminated (Investigator left University No results are possible)
First Posted : April 11, 2012
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This proposal has been developed through collaboration between the University of Minnesota and New American Community Services (NACS), and the research design is based on a needs assessment conducted by the community partner. The investigators will test the hypotheses that women who are offered home vaginal bio-specimen collection will have higher rate of cervical cancer screening completion than that of women referred for clinic-based Pap test. All participants will be given identical education materials on cervical cancer screening and HPV, currently in use by the Minnesota Sage Program.

Condition or disease
Cervical Cancer

Detailed Description:
The trial will pilot text a protocol for home vaginal bio-specimen collection for human papillomavirus (HPV) testing for cervical cancer screening. The main objective is to estimate the successful screening completion rate among a sample of Somali women who have not undergone cervical cancer screening for three or more years. Women will be randomized to either home vaginal bio-specimen collection or referral to undergo a clinic-based Pap test.

Study Design

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Minnesota Community Networks Center for Eliminating Cancer Disparities: Cervical Cancer Screening Project Part C Quantitative
Study Start Date : June 2012
Primary Completion Date : May 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Home Based Vaginal Collection
Somali women who are randomized for Home based Vaginal Collection will be given a kit to perform the vaginal sample collection for HPV analysis, with detailed written instructions.
Clinic Based Pap Test Collection
30 Somali women who are randomized for Standard Clinic Pap Group will be given a list of clinics that they can attend for cervical cancer screening using pap test. Follow-up will be done on test completion with the clinic at 3 months after enrollment.


Outcome Measures

Primary Outcome Measures :
  1. Number of home vaginal bio-specimen collections compared to standard clinic-based Pap test [ Time Frame: Within 3 months after Enrollment ]
    The main outcome will be successful completion of cervical cancer screening by 3 months after enrollment. For the Home Vaginal Biospecimen Collection Group, completion is defined as return of the HPV DNA self-sampling kit by the patient, with a sample suitable for laboratory analysis. In the Clinic Pap Test Group, completion is defined by documentation of Pap test result.


Biospecimen Retention:   Samples With DNA
Home based or clinic based HPV test (Pap) collection

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Somali female - Participants may speak Somali or English as their primary language.
Criteria

Inclusion Criteria:

  • Somali female age 25-70 years

    • have lived in the U.S. 10 years or less
    • have not had a Pap test (by self report) in the last 3 years

Exclusion Criteria:

  • Women with a self reported past history of any of the following will not be eligible:

    • total hysterectomy
    • cervical cancer
    • active history of cervical dysplasia
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575444


Locations
United States, Minnesota
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Rahel Ghebre, M.D. Masonic Cancer Center, University of Minnesota
More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01575444     History of Changes
Other Study ID Numbers: 2010NTLS097
First Posted: April 11, 2012    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Pap test
HPV testing
cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female