Cervical Cancer Screening Project Part C

December 8, 2017 updated by: University of Minnesota

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

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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Masonic Cancer Center, University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Somali female - Participants may speak Somali or English as their primary language.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 3 months after Enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Rahel Ghebre, M.D., Masonic Cancer Center, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

April 10, 2012

First Submitted That Met QC Criteria

April 10, 2012

First Posted (Estimate)

April 11, 2012

Study Record Updates

Last Update Posted (Actual)

December 12, 2017

Last Update Submitted That Met QC Criteria

December 8, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010NTLS097

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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