Self-Collection HPV Testing for Cervical Cancer Prevention
Recruiting in Palo Alto (17 mi)
+24 other locations
Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: National Cancer Institute (NCI)
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?This clinical trial evaluates the use of self-collected vaginal samples for human papillomavirus (HPV) testing in patients referred for a colposcopy and/or cervical excisional procedures to improve cervical cancer prevention. HPV is a common virus which usually causes infections that last only a few months, but sometimes can last longer. It is known to cause a variety of cancers including cancer of the cervix. Even though there are ways to detect cervical cancer early, many individuals do not undergo screening that involves pelvic exams. Over half of all new cervical cancer cases are among those who have either never been screened or who are not screened enough. Without appropriate screening and care, preventable pre-cancers may turn into cancer. A new way to detect cervical cancer is to have individuals collect their own vaginal sample for HPV testing to know their risk for cervical cancer. This may give individuals more flexibility and comfort having the ability to collect samples themselves, compared to a doctor performing a speculum examination and collecting the samples in a clinic. This study compares clinical accuracy of HPV testing on self-collected vaginal samples versus cervical samples collected by clinician.
The Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial is part of the National Cancer Institute (NCI)'s Cervical Cancer 'Last Mile' Initiative, a public private partnership that seeks to increase access to cervical cancer screening. The SHIP Trial focuses on developing clinical evidence to inform the US Food and Drug Administration (FDA)'s regulatory reviews of self-collection approaches as alternative sample collection approaches for cervical cancer screening. Several industry partner-specific self-collection device and assay combinations will be non-competitively and independently evaluated with a similar study design framework to inform pre-approval and/or post-approval regulatory requirements.
Is self-collection HPV testing safe for humans?
Research indicates that self-collection HPV testing is a safe method for cervical cancer screening, with performance comparable to samples collected by healthcare providers.
12467What data supports the effectiveness of the treatment HPV Self-Collection for cervical cancer prevention?
Research shows that self-collected HPV testing is as effective as clinician-collected samples in detecting HPV, which is important for cervical cancer screening. This method can help increase screening rates, especially for women who do not regularly attend clinic screenings.
34569How is HPV self-collection testing different from other cervical cancer screening methods?
HPV self-collection testing allows individuals to collect their own samples at home, which can increase participation in cervical cancer screening by reducing barriers like clinic visits. This method has shown comparable accuracy to samples collected by healthcare providers and is cost-effective, making it a promising alternative for those who are infrequently screened.
24589Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
Eligibility Criteria
This trial is for individuals who need a colposcopy or cervical excisional procedure and are interested in self-collecting vaginal samples for HPV testing to prevent cervical cancer. It's part of an initiative to make screening more accessible, especially for those who avoid traditional pelvic exams.Inclusion Criteria
I am 25 years old or older.
I am willing and able to sign a consent form.
My cervix has not been removed.
I am willing to undergo procedures to examine and treat my cervix.
Exclusion Criteria
I have had surgery or treatment to remove part of my cervix in the last year.
I have had a hysterectomy.
I am experiencing unusual bleeding or pelvic pain.
Participant Groups
The SHIP Trial evaluates the clinical accuracy of HPV testing on self-collected vaginal samples versus clinician-collected cervical samples. The goal is to inform FDA regulatory reviews of self-collection methods as alternatives for cervical cancer screening.
1Treatment groups
Experimental Treatment
Group I: Prevention (self-collected and clinician-collected samples)Experimental Treatment10 Interventions
Patients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with or without biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
HPV Self-Collection is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as HPV Self-Collection for:
- Cervical cancer screening
- Cervical cancer prevention
🇪🇺 Approved in European Union as HPV Self-Testing for:
- Cervical cancer screening
- Cervical cancer prevention
🇨🇦 Approved in Canada as Self-Collected HPV Sampling for:
- Cervical cancer screening
- Cervical cancer prevention
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
University of New Mexico Cancer CenterAlbuquerque, NM
University of Alabama at Birmingham Cancer CenterBirmingham, AL
UCSF Medical Center-ParnassusSan Francisco, CA
More Trial Locations
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Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
References
The potential role of self-sampling for high-risk human papillomavirus detection in cervical cancer screening. [2022]High-risk human papillomavirus (hr-HPV) detection will become an important tool in the screening for cervical cancer. Self-sampling is an inexpensive and well-accepted method for HPV detection that will increase participation of nonresponders in current screening programs. Even more, because self-collected samples are as good as physician-collected samples for HPV detection, self-sampling might be a suitable method for future primary cervical cancer screening.
[Self-collection of test material. Supplement to cervical cancer screening]. [2022]Recent studies have reported high sensitivity of human papillomavirus (HPV) testing from self-collected vaginal specimens. These results suggest the possibility of introducing self-collection of samples for cervical cancer screening to increase overall participation. The current study compared test results from self-collected and physician-collected specimens.
Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. [2022]Screening for human papillomavirus (HPV) infection is more effective in reducing the incidence of cervical cancer than screening using Pap smears. Moreover, HPV testing can be done on a vaginal sample self-taken by a woman, which offers an opportunity to improve screening coverage. However, the clinical accuracy of HPV testing on self-samples is not well-known. We assessed whether HPV testing on self-collected samples is equivalent to HPV testing on samples collected by clinicians.
Performance of self-collected cervical samples in screening for future precancer using human papillomavirus DNA testing. [2022]Self-collected human papillomavirus (HPV) testing could reduce barriers to cervical cancer screening, with performance comparable to clinician-collected specimens. The ability of self-collected specimens to cross-sectionally and prospectively detect precursor lesions was investigated in an HPV vaccine randomized trial in Costa Rica.
Mailed Human Papillomavirus Self-Collection With Papanicolaou Test Referral for Infrequently Screened Women in the United States. [2020]Testing for high-risk human papillomavirus (HPV) infection using mailed, self-collected samples is a promising approach to increase screening in women who do not attend clinic screening at recommended intervals.
Performance of human papillomavirus testing on self-collected versus clinician-collected samples for the detection of cervical intraepithelial neoplasia of grade 2 or worse: a randomised, paired screen-positive, non-inferiority trial. [2022]Human papillomavirus (HPV) testing on self-collected samples is a potential alternative to HPV testing on clinician-collected samples, but non-inferiority of its clinical accuracy remains to be assessed in the regular screening population. The IMPROVE study was done to evaluate the clinical accuracy of primary HPV testing on self-collected samples within an organised screening setting.
Extended HPV Genotyping to Compare HPV Type Distribution in Self- and Provider-Collected Samples for Cervical Cancer Screening. [2021]Primary high-risk human papillomavirus (hr-HPV) testing of self-collected cervico-vaginal swabs could increase cervical cancer screening coverage, although triage strategies are needed to reduce unnecessary colposcopies. We evaluated the use of extended hr-HPV genotyping of self-collected samples for cervical cancer screening.
HPV self-collection: what are we waiting for? Exploration of attitudes from frontline healthcare providers. [2023]Polymerase chain reaction based human papilloma virus (HPV) self-collection for cervical cancer screening is well established. It is utilized worldwide, accepted by patients, is cost-effective, has comparable sensitivity to provider-collected samples, and increases screening rates, however clinical practice in the United States has not shifted to include HPV self-collection. This study sought to examine provider knowledge and attitudes to better understand why HPV self-collection is not being utilized.
Evaluation of the applicability of internal controls on self-collected samples for high-risk human papillomavirus is needed. [2023]Self-collection of cervical samples to detect high-risk human papillomavirus (hr-HPV) is a trending topic in primary cervical cancer screening. This study evaluates the applicability of a self-sampling device to routine molecular procedures for hr-HPV detection.