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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Q-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 laborat

Первичные конечные точки

• Clinical Performance vs Histology [Срок оценки: Through study completion, an average of 1 year.]
• Proportion of participants with at least one reportable device-related adverse event (ADE or SADE) [Срок оценки: Through study completion, an average of 1 year.]

Вторичные конечные точки (2)

• Positive, negative, and overall percent agreement between Q-Pad hrHPV testing and clinician-collected cervical hrHPV testing [Срок оценки: Through study completion, an average of 1 year.]
• Q-Pad hrHPV Test System validity rate and participant usability/acceptability [Срок оценки: Through study completion, an average of 1 year.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 3 центра

• Planned Parenthood of Southern New England — New Haven
• Planned Parenthood North Central States — Minneapolis
• Planned Parenthood of Greater Ohio (PPGOH) — Akron

Публикации

• Arbyn M, Peeters E, Benoy I, Vanden Broeck D, Bogers J, De Sutter P, Donders G, Tjalma W, Weyers S, Cuschieri K, Poljak M, Bonde J, Cocuzza C, Zhao FH, Van Keer S, Vorsters A. VALHUDES: A protocol for validation of human papillomavirus assays and collection devices for HPV testing on self-samples and urine samples. J Clin Virol. 2018 Oct;107:52-56. doi: 10.1016/j.jcv.2018.08.006. Epub 2018 Aug 22. PMID 30195193
• Naseri S, Young S, Cruz G, Blumenthal PD. Screening for High-Risk Human Papillomavirus Using Passive, Self-Collected Menstrual Blood. Obstet Gynecol. 2022 Sep 1;140(3):470-476. doi: 10.1097/AOG.0000000000004904. Epub 2022 Aug 3. PMID 35926207
• U.S. Food and Drug Administration, "510(k) Substantial Equivalence Determination Decision Summary: Q-Pad A1c Test System (K231465)," 2023, accessed June 11, 2025, https://www.accessdata.fda.gov/cdrh_docs/pdf23/K231465.pdf.

Идентификаторы

NCT: NCT07281599 · ALM_QT2/DOC-392

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗