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

Qurasense

Status: Enrolling

Conditions: Screening Test; Cervical Cancer (Early Detection); HPV DNA; HPV; HPV Infection; Cervical Cancer Cin Grade; HPV Infections; Cervical Cancer Screening; HPV (Human Papillomavirus)-Associated; High Risk HPV; HPV 16 Infection

Treatments: Device: Q-Pad hrHPV Test System

Study type: Interventional

Funder types: Industry

Identifiers

NCT07281599

ALM_QT2/DOC-392

Details and patient eligibility

About

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.

Full description

The EQUIP Study is a prospective, multicenter method-comparison study designed to evaluate the diagnostic performance of the Q-Pad hrHPV Test System for cervical cancer screening. Menstruating adults referred for colposcopy after an abnormal cervical screening result receive a mailed Q-Pad Kit and use it during the menstrual cycle immediately after their clinic visit to collect a menstrual samples at home, guided by written instructions and an optional accompanying smartphone application. These samples are returned by mail to a central laboratory, where hrHPV testing is performed using a PCR assay.

At the colposcopy visit, clinicians obtain a standard cervical specimen for routine cytology and hrHPV testing on the same assay platform and perform colposcopy with biopsy as clinically indicated. Each participant therefore provides both an at-home menstrual sample (index test) and a clinician-collected cervical sample (comparator) within the same episode of care, with biopsy and histopathology providing disease status. The study focuses on comparing hrHPV results between the two specimen types and on evaluating safety, specimen adequacy, and participant usability and acceptability of the Q-Pad at-home menstrual collection approach.

Enrollment: 450 estimated patients

Sex: Female

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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450 participants in 1 patient group

Non-invasive, passive self-collection / Clinician collection

Other group

Description:

Participants referred for colposcopy after abnormal cervical screening will collect menstrual blood at home using the Q-Pad kit and mail the sample for hrHPV testing. At the colposcopy visit, they will have a clinician-collected cervical specimen obtained for hrHPV testing and undergo colposcopy with biopsy as part of standard care.

Treatment:

Device: Q-Pad hrHPV Test System