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Cervical Cancer Screening Project Part C

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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 15, 2014
Last verified: May 2014
  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
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 15, 2014
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
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014