Human Papillomavirus (HPV) Infection
Conditions
Brief summary
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.
Interventions
DEVICEEndometrics Menstrual Blood Collection Kit
Investigational 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.
Sponsors
Samantha Batman
Endometrics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Can read, understand, and communicate in English. * Are willing and able to follow study procedures, including using a menstrual blood collection kit and returning the sample for testing. * Are willing to provide informed consent before any study procedures are performed. * May be of any race or ethnicity.
Exclusion criteria
* 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. * Have a medical, mental health, cognitive, social, or other condition that, in the opinion of the study doctor, could make it difficult to safely participate or complete the study procedures. * Are unable to understand the study requirements, use the collection kit, or return the sample for testing. * Do not wish to participate, withdraw consent, or are unwilling to complete the required study procedures. * Are taking part in another research study or have another circumstance that, in the opinion of the study team, could affect study results or participant safety. * Are currently incarcerated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concordance of HPV Detection Between Menstrual Blood and Clinical HPV Testing | At completion of HPV testing, up to 75 days | 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. |
Countries
United States
Contacts
CONTACTSamantha Batman, ND
Outcome results
None listed