HPV Detection Using Self-Collected Menstrual Blood

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-49
SponsorSamantha Batman

About this trial

This study is evaluating whether human papillomavirus (HPV) can be accurately detected from self-collected menstrual blood samples. Participants who have had routine clinical HPV testing within the previous 90 days will collect a menstrual blood sample at home using a study-provided collection kit. The HPV test result from the menstrual blood sample will be compared with the participant's prior clinical HPV test result to assess agreement between the two methods. The goal is to determine whether menstrual blood collection may provide a feasible, noninvasive approach for HPV testing.

Eligibility criteria

Qualifiers

Are 21 to 49 years old.

Are female, have not yet gone through menopause, and expect to have a menstrual period during the study.

Have a cervix (have not had a hysterectomy that removed the cervix). Had a routine high-risk HPV (human papillomavirus) test within the past 90 days and received a valid result (positive or negative).

Receive medical care at the participating clinic and have been identified by the study team as a possible candidate for the study.

Disqualifiers

Had an HPV test in the past 90 days, but the result was unclear, invalid, or could not be interpreted.

Are currently pregnant.

Have had a hysterectomy that removed the cervix.

Are not currently having menstrual periods or are unable to provide a menstrual blood sample during the study period.

Trial design

Treatments tested in this trial

  • Endometrics Menstrual Blood Collection Kit

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Samantha Batman

Lead sponsor

University of Virginia

Sponsor institution

Endometrics

Collaborator