This study investigates the use of menstrual blood in screening for HPV-related cervical cancer in participants with and without a history of high risk HPV infection. Collecting menstrual blood for HPV detection may help doctors find cervical cancer sooner, when it may be easier to treat.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03638427.
PRIMARY OBJECTIVES:
I. To compare the accuracy and percent analytic agreement of clinician- and self-collected cervico-vaginal brush samples with Q-pad-collected menstrual blood for high risk human papillomavirus (HR-HPV) detection in HR-HPV positive women and women with no previous history of HR-HPV.
II. To assess the ability to detect oncoproteins in Q-pad collected menstrual blood samples from women with atypical squamous cell of undetermined significance positive (ASCUS+) to determine the utility in cervical cancer/precancer detection.
III. To test the utility of a low and high threshold HR-HPV reflex scheme to similarly increase the specificity of HR-HPV testing derived from menstrual blood.
OUTLINE:
Participants undergo self-collection of menstrual blood samples using Q-pads. Participants also undergo standard of care screening for HR-HPV. Within 18 months, participants with a positive HR-HPV test undergo a repeat pap smear, colposcopy, or loop electrosurgical excision procedure. Participants with a positive HR-HPV also undergo self-collection of 2 additional self-swabs.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorPaul Blumenthal
