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NCT07281599 · ClinicalTrials.gov registry record · NA
Evaluation of the Q-Pad hrHPV Test System for Identifying Precancer
A NA study of Hpv and HPV Infection, sponsored by Qurasense.
- Recruiting
- Registry status
- NA
- Development phase
- 450
- Enrollment target
- 4
- Study locations
NCT07281599: Recruiting NA study of Hpv and HPV Infection, sponsored by Qurasense.
NCT07281599 is a NA study of Hpv and HPV Infection that is actively recruiting participants, run by Qurasense. The registered enrollment target is 450 participants, below the 2,223-participant average among 24 other Hpv trials with a reported enrollment target (80% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07281599, a NA study of Hpv and HPV Infection, is actively recruiting participants, sponsored by Qurasense.
- RECRUITING
- Registry status
- NA
- Development phase
- 450 participants
- Enrollment target
- 4
- Study locations
Study Summary
The EQUIP Study is testing whether high-risk human papillomavirus (hrHPV), the virus that causes most cervical cancers, can be accurately detected from menstrual blood collected at home. People who have been referred for colposcopy after an abnormal Pap or hrHPV test will use the Q-Pad Kit during their period to collect menstrual samples on a special menstrual pad and mail them to a central laboratory for hrHPV testing. The same participants will have a standard cervical sample collected for routine hrHPV testing and will undergo colposcopy as part of their usual care. By comparing hrHPV results from menstrual samples with results from cervical samples and biopsy findings, the study will evaluate how well the Q-Pad hrHPV Test System detects cervical precancer and will also assess how easy and acceptable it is for participants to use this at-home collection method.
Primary Outcome
Clinical sensitivity defined as the proportion of participants with biopsy-confirmed CIN2+ whose menstrual-blood hrHPV result (Q-Pad hrHPV Test System) is positive and Clinical specificity defined as the proportion of participants with \<CIN2 on histology whose menstrual-blood hrHPV result is negative.
Conditions Studied
Interventions
- DEVICE Q-Pad hrHPV Test System
Study Locations (4)
Connecticut
- Planned Parenthood of Southern New England - New Haven
Minnesota
- Planned Parenthood North Central States - Minneapolis
Ohio
- Planned Parenthood of Greater Ohio (PPGOH) - Akron
Utah
- Planned Parenthood Association of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2025-12-01 |
| Est. Completion | 2027-03 |
| Phase | NA |
What NCT07281599 shows while recruiting
NCT07281599 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, below the 2,223-participant average among 24 other Hpv trials with a reported enrollment target (80% lower).
The record links to 10 conditions, with Hpv appearing as the primary indexed condition, and to 1 intervention - of which Q-Pad hrHPV Test System is the first listed.
NCT07281599 reports a single indexed study location in Connecticut, Minnesota, Ohio.
Frequently Asked Questions
What is clinical trial NCT07281599 about?
NCT07281599 is a clinical study titled "Evaluation of the Q-Pad hrHPV Test System for Identifying Precancer". The EQUIP Study is testing whether high-risk human papillomavirus (hrHPV), the virus that causes most cervical cancers, can be accurately detected from menstrual blood collected at home. People who have been referred for colposcopy after an abnormal Pap or hrHPV test will use the Q-Pad Kit during th...
What is the current status of trial NCT07281599?
This trial is currently recruiting. It is a NA study. The enrollment target is 450 participants. The study started on 2025-12-01. Estimated completion is 2027-03.
What conditions does trial NCT07281599 study?
This clinical trial studies the following conditions: Hpv, HPV Infection, Cervical Cancer Screening, HPV 16 Infection, High Risk HPV.
What interventions are being tested in trial NCT07281599?
The interventions under investigation include: Q-Pad hrHPV Test System (DEVICE).
Who is sponsoring clinical trial NCT07281599?
This trial is sponsored by Qurasense, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07281599 being conducted?
This trial has 4 study locations across Connecticut, Minnesota, Ohio, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07281599's enrollment target sits among peer trials
450 10th of 24 higher than 15 of 24 other Hpv trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hpv trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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