HPV Detection Using Self-Collected Menstrual Blood
ConditionHuman Papillomavirus (HPV) Infection
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Endometrics Menstrual Blood Collection Kit
DeviceInvestigational self-collection menstrual blood sampling kit used to collect menstrual blood specimens for HPV testing and concordance assessment with prior routine clinical HPV test results.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Menstrual Blood Self-CollectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Concordance of HPV Detection Between Menstrual Blood and Clinical HPV Testing
Agreement between high-risk HPV test results obtained from self-collected menstrual blood specimens and prior routine clinical cervical HPV test results. Concordance will be assessed for HPV16 positive, HPV18 positive, pooled high-risk HPV positive, and HPV negative categories. Supportive analyses may include positive percent agreement and negative percent agreement.
Time frame
At completion of HPV testing, up to 75 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: