Q-Pad hrHPV Test for Cervical Cancer Screening
(EQUIP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if the Q-Pad hrHPV Test System can detect high-risk human papillomavirus (hrHPV), the primary cause of most cervical cancers, using menstrual blood collected at home. Participants will collect samples with a special pad during their period and mail them for testing. The trial will compare these results with those from standard cervical samples and biopsies to assess accuracy and ease of use. Individuals referred for a colposcopy after an abnormal Pap or HPV test and who have regular periods might be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could simplify cervical cancer screening.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that the Q-Pad hrHPV Test System is safe for cervical cancer screening?
Research has shown that the Q-Pad hrHPV Test System safely detects high-risk human papillomavirus (hrHPV) from menstrual blood. This virus causes most cervical cancers. The test uses a special menstrual pad for sample collection at home, which participants then mail to a lab for testing.
No direct evidence from studies indicates safety concerns or side effects from using this test. However, since the trial focuses on evaluating the method's effectiveness rather than testing a new drug or invasive procedure, the risk of harm appears low. Participants simply collect menstrual blood, a non-invasive process.
In terms of general safety, the test compares results from menstrual samples with standard cervical samples, suggesting that the Q-Pad test is as safe as current cervical screening methods. Overall, the emphasis is on convenience and accuracy without compromising participant safety.12345Why are researchers excited about this trial?
Researchers are excited about the Q-Pad hrHPV Test System because it offers a non-invasive, self-collection method for screening high-risk human papillomavirus (hrHPV), which is linked to cervical cancer. Unlike the traditional Pap smear or clinician-collected samples, this test allows women to collect menstrual blood at home using a simple kit and mail it in for analysis. This approach could increase accessibility and convenience, leading to higher participation rates in cervical cancer screening, particularly among women who are uncomfortable with or unable to access in-clinic testing.
What evidence suggests that the Q-Pad hrHPV Test System is effective for detecting cervical precancer?
Research has shown that the Q-Pad hrHPV Test System, which detects high-risk HPV (human papillomavirus) using menstrual blood, is promising. In this trial, participants will use the Q-Pad kit for self-collection at home and mail the sample for hrHPV testing. Studies have found that this test closely matches results from samples collected by doctors, with agreement rates between 95-100%. This indicates the test's effectiveness in detecting HPV, which is crucial because HPV can lead to cervical cancer. These findings suggest that the Q-Pad test could serve as an effective and reliable at-home screening tool for HPV, offering a convenient alternative to traditional methods.16789
Who Is on the Research Team?
Paul Blumenthal, MD, MPH
Principal Investigator
Are You a Good Fit for This Trial?
The trial is for individuals referred for colposcopy after an abnormal Pap or hrHPV test. Participants will collect menstrual blood at home using the Q-Pad Kit and send it to a lab for testing. They must be comfortable with self-collection and mailing samples, as well as attending clinic visits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Self-collection
Participants collect menstrual blood at home using the Q-Pad kit and mail the sample for hrHPV testing
Clinic Visit
Participants have a clinician-collected cervical specimen obtained for hrHPV testing and undergo colposcopy with biopsy as part of standard care
Follow-up
Participants are monitored for safety and effectiveness after the clinic visit
What Are the Treatments Tested in This Trial?
Interventions
- Q-Pad hrHPV Test System
Trial Overview
The EQUIP Study is evaluating the effectiveness of the Q-Pad hrHPV Test System in detecting high-risk human papillomavirus from menstrual blood compared to standard cervical samples during routine care.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Qurasense
Lead Sponsor
Citations
Evaluation of the Q-Pad hrHPV Test System for Identifying ...
The EQUIP Study is a prospective, multicenter method-comparison study designed to evaluate the diagnostic performance of the Q-Pad hrHPV Test ...
Real-world effectiveness of cytology and HPV-based ...
Ultimately, 824 cases of high-grade lesions and cervical cancer were detected, with a total detection rate of cervical cancer and precancerous ...
3.
journals.lww.com
journals.lww.com/greenjournal/abstract/2022/05001/screening_for_high_risk_human_papillomavirus_using.91.aspxScreening for High Risk Human Papillomavirus Using...
CONCLUSION: Among HPV-positive women, the Q-Pad showed highly concordant results (95-100%) compared to clinician-collected sampling. This collection ...
Advancing Cervical Cancer Prevention Equity: Innovations ...
Prophylactic HPV vaccines have demonstrated efficacy, achieving up to 90% reduction in HPV infections and 85% reduction in high-grade cervical lesions among ...
Cervical Cancer Screening (PDQ®) - NCI
Magnitude of Effect: Regular Pap screening decreases cervix cancer incidence and mortality by at least 80%. Study Design: Population-based and ...
6.
ctv.veeva.com
ctv.veeva.com/study/evaluation-of-the-q-pad-hrhpv-test-system-for-identifying-precancerEvaluation of the Q-Pad hrHPV Test System for Identifying ...
The EQUIP Study is testing whether high-risk human papillomavirus (hrHPV), the virus that causes most cervical cancers, can be accurately ...
Human Papillomavirus and Cervical Cancer - PMC
The association between certain oncogenic (high-risk) strains of HPV and cervical cancer is well established.
Summary of Safety and Effectiveness Data (SSED)
This test detects the high-risk HPV types 16, 18, 31, 33, 35, 39,. 45, 51, 52, 56, 58, 59, 66, and 68. cobas HPV is indicated for use for routine cervical ...
Updated Cervical Cancer Screening Guidelines
There are now three recommended options for cervical cancer screening in individuals aged 30–65 years: primary hrHPV testing every 5 years, cervical cytology ...
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