Screening for Cervical Intraepithelial Neoplasia Using Self-collected Menstrual Blood
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Infectious Disease, Women's Studies |
| Therapuetic Areas: | Immunology / Infectious Diseases, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 2/8/2019 |
| Start Date: | January 1, 2019 |
| End Date: | December 1, 2020 |
The purpose of this study is to investigate the feasibility and efficacy of assessing HR-HPV
DNA and HPV E6/E7 mRNA via self-collected menstrual blood in a smart menstrual pad. In other
words, can the investigators detect the high risk strains of the human papilloma virus (HPV)
that are associated with cervical cancer in self-collected menstrual blood, as an alternative
to collecting vaginal swabs.
DNA and HPV E6/E7 mRNA via self-collected menstrual blood in a smart menstrual pad. In other
words, can the investigators detect the high risk strains of the human papilloma virus (HPV)
that are associated with cervical cancer in self-collected menstrual blood, as an alternative
to collecting vaginal swabs.
Inclusion Criteria:
- Women in the age group 18-45 and
- who are menstruating and
- who have been tested HR-HPV positive and
- who can commit to have protected sex using condoms if they change sexual partners in
the time frame from self-collection and provider collected samples.
Exclusion Criteria:
- Women younger than 18 years old or older than 45 years old or who are post menopausal
or not menstruating regularly and who are not HR-HPV positive and who cannot commit to
have protected sex using condoms if they change sexual partners in the time frame from
self-collection and provider collected samples.
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