NCT07281599 Evaluation of the Q-Pad hrHPV Test System for Identifying Precancer
| NCT ID | NCT07281599 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Qurasense |
| Condition | HPV Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 450 participants in total. It began in 2025-12-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * You are 25 years old or older and have an intact cervix. * You were referred for a colposcopy after an abnormal Pap or HPV screen. * Your periods come regularly-about every 21-35 days. * You own a smartphone, have an email address, and can read the Qvin app instructions in English. * You are willing to sign the consent form (electronically). * You agree to use a condom for any vaginal intercourse or shared penetrative toy use from Q-Pad collection until the colposcopy visit if engaging with a new sexual partner during this period. Exclusion Criteria: * You are pregnant or think you might be. * You are unwilling or unable to use the two Q-Pads and mail them back (mailing costs are covered). * You had treatment for cervical pre-cancer (CIN2+)-such as LEEP, cone, or ablation-within the last 12 months. * You have already joined this study or are in another cervical-screening / HPV study right now.
Contact & Investigator
Paul Blumenthal, MD, MPH
STUDY DIRECTOR
Frequently Asked Questions
Who can join the NCT07281599 clinical trial?
This trial is open to female participants only, aged 25 Years or older, studying HPV Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07281599 currently recruiting?
Yes, NCT07281599 is actively recruiting participants. Contact the research team at care@qvin.com for enrollment information.
Where is the NCT07281599 trial being conducted?
This trial is being conducted at New Haven, United States, Minneapolis, United States, Akron, United States.
Who is sponsoring the NCT07281599 clinical trial?
NCT07281599 is sponsored by Qurasense. The principal investigator is Paul Blumenthal, MD, MPH. The trial plans to enroll 450 participants.