The Selfie Study- Assessing Novel Markers for Cervical Cancer Screening From Self-collected Samples

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

Cervical cancer is primarily caused by Human Papillomaviruses (HPV). Testing for HPV in cervical samples is now an option for cervical cancer screening. HPV can also be tested from self-collected samples which may help to improve access to screening, since it does not require a doctor visit. However, many women will test positive for HPV who are not at high risk for cervical cancer. Therefore, additional (triage) tests are needed to determine which women testing HPV-positive require additional clinical workup. For self sampling, a triage test that could be measured from the same initial sample without requiring a follow-up visit to the doctor would be an ideal strategy. The purpose of this study is to determine whether a new HPV test that measures changes in HPV DNA can be used to triage HPV-positive women using self collected samples. This study will enroll 1,000 women who are undergoing cervical cancer screening at the George Washington University. Women will be asked to take a self-collected sample prior to their clinic visit. The investigators will evaluate the clinical accuracy of the new HPV triage test in self-collected samples and compare the accuracy of the test in samples collected by the clinician.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 30
Maximum Age: 69
Healthy Volunteers: t
View:

• Female

• Age 30-69

• Undergoing cervical cancer screening, diagnostic procedure (colposcopy), or treatment (LEEP)

Locations
United States
Washington, D.c.
Medical Faculty Associates
RECRUITING
Washington D.c.
Contact Information
Primary
Nicole Chappell, MD
nChappell@mfa.gwu.edu
202 741 2434
Time Frame
Start Date: 2020-08-15
Estimated Completion Date: 2025-08
Participants
Target number of participants: 1000
Treatments
CIN2+
Cases of cervical precancer will include women diagnosed with cervical intraepithelial grades 2 or 3 (CIN2/3) or adenocarcinoma in situ (AIS). If any women are diagnosed with cancer in the study, they will be included in this group.
< CIN2
Non-cases will include those with \<CIN2 on colposcopy/biopsy and women who did not have an indication for colposcopy (because of a negative screening test).
Related Therapeutic Areas
Sponsors
Leads: George Washington University
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov