This clinical trial evaluates how well a self-collection method detects human papillomavirus (HPV) in screening for cervical cancer. Cervical cancer is preventable through screening for HPV, yet there has been a decline in screening rates. Screening for HPV may help doctors find cervical cancer sooner, when it may be easier to treat or cure. In-home self-collection methods may increase access to HPV screening and increase early diagnosis of cervical cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05600283.
PRIMARY OBJECTIVE:
I. To validate a patient self-sampling vaginal collection kit and laboratory testing for the detection of HPV infection.
SECONDARY OBJECTIVE:
I. To assess the patient perspective on acceptability and feasibility of a self-sampling approach to cervical cancer screening through a survey of study enrollees.
OUTLINE:
Patients undergo self-collection HPV testing using the Evalyn kit and then undergo clinician-collection HPV testing during scheduled gynecology appointment on study.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorKathy Lynn Maclaughlin