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NCT03638427 · ClinicalTrials.gov registry record
Screening for Cervical Intraepithelial Neoplasia Using Self-collected Menstrual Blood
A clinical trial, sponsored by Stanford University.
- Completed
- Registry status
- 159
- Enrollment target
NCT03638427: Completed study, sponsored by Stanford University.
NCT03638427 is a clinical trial that has completed, run by Stanford University. The registered enrollment target is 159 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03638427 has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- 159 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The clinician collected a vaginal swab to detect HPV, then participants used a modified menstrual pad to self-collect a sample within 2 months of the clinician collected swab (may have happened at up to 4 mo.). Participants may have had prior history of dysplasia or HPV positivity, or were from general population receiving regular check-up. Agreement between the clinician-collected swabs and participant-collected menstrual samples was assessed in: * Participants who sent their sample to the la
Interventions
- DIAGNOSTIC_TEST Menstrual Blood Analysis (Menstrual Blood Analysis)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2019-01-01 |
| Est. Completion | 2022-11-30 |
What the finished NCT03638427 record still lists
NCT03638427 is an observational study that tracks outcomes without assigning an intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Menstrual Blood Analysis (Menstrual Blood Analysis) is the first listed.
NCT03638427 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03638427 about?
NCT03638427 is a clinical study titled "Screening for Cervical Intraepithelial Neoplasia Using Self-collected Menstrual Blood". 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 w...
What is the current status of trial NCT03638427?
This trial is currently completed. The enrollment target is 159 participants. The study started on 2019-01-01. Estimated completion is 2022-11-30.
What interventions are being tested in trial NCT03638427?
The interventions under investigation include: Menstrual Blood Analysis (Menstrual Blood Analysis) (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03638427?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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