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Minnesota Community Networks Center for Eliminating Cancer Disparities: Cervical Cancer Screening Project Part C Quantitative


N/A
25 Years
70 Years
Open (Enrolling)
Female
Cervical Cancer

Thank you

Trial Information

Minnesota Community Networks Center for Eliminating Cancer Disparities: Cervical Cancer Screening Project Part C Quantitative


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Number of home vaginal bio-specimen collections compared to standard clinic-based Pap test

Outcome Description:

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.

Outcome Time Frame:

Within 3 months after Enrollment

Safety Issue:

No

Principal Investigator

Rahel Ghebre, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Institutional Review Board

Study ID:

2010NTLS097

NCT ID:

NCT01575444

Start Date:

June 2012

Completion Date:

May 2014

Related Keywords:

  • Cervical Cancer
  • Pap test
  • HPV testing
  • cervical cancer
  • Uterine Cervical Neoplasms

Name

Location
Masonic Cancer Center, University of Minnesota Minneapolis, Minnesota  55455