RecruitingNot ApplicableNCT07281599

Evaluation of the Q-Pad hrHPV Test System for Identifying Precancer

Sponsor

Qurasense

Enrollment

450 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

HPV Infection HPV 16 Infection

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

Sex: FEMALEMin Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a menstrual pad (Q-Pad) used at home to collect a small blood sample can accurately detect high-risk HPV — the virus that can lead to cervical cancer — compared to tests done in a clinic. **You may be eligible if...** - You are 25 years or older with an intact cervix - You were referred for a colposcopy (a closer look at the cervix) after an abnormal Pap smear or HPV test - Your menstrual cycle comes regularly (every 21–35 days) - You own a smartphone and an email address, and can read English instructions - You are willing to sign consent electronically **You may NOT be eligible if...** - You are pregnant or think you might be - You are unable or unwilling to use the two Q-Pads and mail them back - You have previously had treatment for cervical pre-cancer (like LEEP or cone biopsy) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEQ-Pad hrHPV Test System

Participants will receive a mailed Q-Pad Kit, which includes two Q-Pads (menstrual pads with removable collection strips called Q-Strips), a Q-Strip Container with desiccant for storing and shipping the strips, and a prepaid return mailer. During the menstrual cycle after their colposcopy visit, participants will follow the Instructions for Use to passively collect menstrual blood with the Q-Pads, then remove the Q-Strips and place them in the Q-Strip Container for mailing to the central laboratory for hrHPV testing. At the colposcopy visit, the clinician will also collect a cervical sample in ThinPrep liquid-based cytology medium for hrHPV testing, which will serve as the comparator specimen.