Clinical trial · Interventional
Evaluation of the Q-Pad hrHPV Test System for Identifying Precancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer Cin Grade | — | UNRESOLVED | — |
| Cervical Cancer (Early Detection) | Malignant Cervical Neoplasm | CURATED_EXACT | 0.85 |
| Cervical Cancer Screening | — | UNRESOLVED | — |
| High Risk HPV | — | UNRESOLVED | — |
| HPV | — | UNRESOLVED | — |
| HPV 16 Infection | — | UNRESOLVED | — |
| HPV DNA | — | UNRESOLVED | — |
| HPV (Human Papillomavirus)-Associated | — | UNRESOLVED | — |
| HPV Infection | — | UNRESOLVED |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Q-Pad hrHPV Test System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Non-invasive, passive self-collection / Clinician collection
- 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.
- interventionNames
- Device: Q-Pad hrHPV Test System
Primary outcomes (2)
- measure
- Clinical Performance vs Histology
- timeFrame
- Through study completion, an average of 1 year.
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDArbyn 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
- BACKGROUNDNaseri 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
- BACKGROUNDU.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.