Cervical Cancer Screening Project Part C

This study is currently recruiting participants.
Verified May 2013 by Masonic Cancer Center, University of Minnesota
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT01575444
First received: April 10, 2012
Last updated: May 23, 2013
Last verified: May 2013
  Purpose

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
Cervical Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Minnesota Community Networks Center for Eliminating Cancer Disparities: Cervical Cancer Screening Project Part C Quantitative

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Number of home vaginal bio-specimen collections compared to standard clinic-based Pap test [ Time Frame: Within 3 months after Enrollment ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 60
Study Start Date: June 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Home Based Vaginal Collection
Clinic Based Pap Test Collection

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.

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01575444

Contacts
Contact: Rahel Ghebre, M.D. 612-626-5939 ghebr004@umn.edu

Locations
United States, Minnesota
Masonic Cancer Center, University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Rahel Ghebre, M.D.    612-626-5339    ghebr004@umn.edu   
Principal Investigator: Rahel Ghebre, M.D.         
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Rahel Ghebre, M.D. Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT01575444     History of Changes
Other Study ID Numbers: 2010NTLS097
Study First Received: April 10, 2012
Last Updated: May 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Masonic Cancer Center, University of Minnesota:
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

ClinicalTrials.gov processed this record on April 17, 2014