Self-Collection HPV Testing for Cervical Cancer Prevention

Recruiting at 24 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: National Cancer Institute (NCI)

Disqualifiers: Pregnancy, Recent birth, Hysterectomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

500 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What 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. ^{1 2 3 4 5}

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. ^{1 4 6 7 8}

How 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. ^{1 2 3 7 9}

Research Team

Vikrant V Sahasrabuddhe

Principal Investigator

National Cancer Institute Division of Cancer Prevention

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.

I was referred for a colposcopy or cervical procedure due to abnormal cervical cancer screening results in the last year.

Exclusion Criteria

I have had surgery or treatment to remove part of my cervix in the last year.

I have had a hysterectomy.

Previous participation in the SHIP Trial

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Participants undergo self-collection of a vaginal sample and clinician-collection of a cervical test sample

One-time

1 visit (in-person)

Standard of Care Procedures

Participants undergo standard of care colposcopy with or without biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated

One-time

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after sample collection and procedures

Up to 90 days

Treatment Details

Interventions

• HPV Self-Collection

Trial Overview 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.

Participant Groups

Group I: Prevention (self-collected and clinician-collected samples) Experimental Treatment 10 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

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Findings from Research

Self-collected HPV testing demonstrated high sensitivity (88.7%) for detecting existing high-grade cervical lesions (CIN2+) and comparable performance to clinician-collected samples, suggesting it is a reliable method for cervical cancer screening.

In a study of 5109 women, self-collected HPV tests were significantly more effective than cytology in predicting new cases of CIN2+, with a sensitivity of 73.9%, highlighting its potential for earlier detection of cervical disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of self-collected cervical samples in screening for future precancer using human papillomavirus DNA testing. Porras, C., Hildesheim, A., González, P., et al.[2022]

A study involving 429 women aged 30 to 65 showed that mailing self-collection kits for HPV testing resulted in a 64% return rate, with 15% of samples testing positive for HPV, indicating a feasible method to increase screening among those overdue for Pap tests.

Women who tested positive for HPV were more likely to follow up with Pap tests (82%) compared to those who tested negative (51%), suggesting that self-testing can effectively encourage further screening and improve overall cervical health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mailed Human Papillomavirus Self-Collection With Papanicolaou Test Referral for Infrequently Screened Women in the United States. Smith, JS., Des Marais, AC., Deal, AM., et al.[2020]

Self-collection of cervical samples for hr-HPV detection showed a significant error rate, with 9.1% of samples at UZ Ghent and 17.6% at AML failing to provide an internal control signal, indicating potential issues with sample quality.

Despite the high error rates, the prevalence of hr-HPV in the valid samples was 18.8%, suggesting that self-collection could still be a viable method for screening, but adjustments in testing protocols may be needed to account for differences in sample collection methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the applicability of internal controls on self-collected samples for high-risk human papillomavirus is needed. Verberckmoes, B., De Vos, T., Maelegheer, K., et al.[2023]

In a study involving over 16,000 women, HPV testing on self-collected samples showed similar accuracy to clinician-collected samples for detecting cervical lesions (CIN2+ and CIN3+), indicating that self-sampling could be a viable option for routine screening.

The study demonstrated that the sensitivity and specificity for detecting significant cervical lesions were not significantly different between self-collected and clinician-collected samples, supporting the use of self-sampling in organized screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Polman, NJ., Ebisch, RMF., Heideman, DAM., et al.[2022]

HPV testing on self-collected samples detected 76% of cervical intraepithelial neoplasia grade 2 (CIN2) or worse and 84% of CIN3 or worse, indicating it is a viable option for screening, especially for women who may not participate in regular screenings.

However, the sensitivity and specificity of HPV testing on self-samples were lower compared to clinician-taken samples, suggesting that while self-sampling can improve access, clinician sampling is still recommended for more accurate results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. Arbyn, M., Verdoodt, F., Snijders, PJ., et al.[2022]

High-risk human papillomavirus (hr-HPV) detection is crucial for cervical cancer screening, and self-sampling is an effective and cost-efficient method that can boost participation among those who typically do not respond to traditional screening.

Self-collected samples for HPV detection are as reliable as those collected by physicians, suggesting that self-sampling could be a viable option for primary cervical cancer screening in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential role of self-sampling for high-risk human papillomavirus detection in cervical cancer screening. Schmeink, CE., Bekkers, RL., Massuger, LF., et al.[2022]

Self-collected vaginal samples for HPV testing showed lower sensitivity (72%) compared to physician-collected samples (92%), indicating that self-collection may not be as reliable for cervical cancer screening.

While self-collected PAP tests had a high positive predictive value, their sensitivity was only 52%, suggesting that self-collection might not improve screening efficiency in cervical cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Self-collection of test material. Supplement to cervical cancer screening]. Mangold, BR.[2022]

Self-collected cervico-vaginal swabs showed a higher positivity rate for high-risk HPV (76%) compared to provider-collected samples (70%), indicating that self-collection could enhance cervical cancer screening coverage.

HPV-16 was the most prevalent genotype in both sample types and had the highest positive predictive value for detecting cervical intraepithelial neoplasia (CIN) grade 2 or higher, suggesting that while self-collection is effective, it may lead to increased referrals for colposcopy due to higher HPV-16 detection rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended HPV Genotyping to Compare HPV Type Distribution in Self- and Provider-Collected Samples for Cervical Cancer Screening. Rohner, E., Edelman, C., Sanusi, B., et al.[2021]

A study involving 18 healthcare providers in Oregon revealed that while there are concerns and barriers to implementing HPV self-collection for cervical cancer screening, there is a strong willingness among providers to offer this option once it becomes available.

Providers believe that HPV self-collection is accepted by patients and emphasize the need for its inclusion in national screening guidelines to enhance cervical cancer screening rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HPV self-collection: what are we waiting for? Exploration of attitudes from frontline healthcare providers. Bohn, JA., Fitch, KC., Currier, JJ., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Performance of self-collected cervical samples in screening for future precancer using human papillomavirus DNA testing. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Mailed Human Papillomavirus Self-Collection With Papanicolaou Test Referral for Infrequently Screened Women in the United States. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Evaluation of the applicability of internal controls on self-collected samples for high-risk human papillomavirus is needed. [2023]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. England pubmed.ncbi.nlm.nih.gov

Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The potential role of self-sampling for high-risk human papillomavirus detection in cervical cancer screening. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

[Self-collection of test material. Supplement to cervical cancer screening]. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Extended HPV Genotyping to Compare HPV Type Distribution in Self- and Provider-Collected Samples for Cervical Cancer Screening. [2021]

9. England pubmed.ncbi.nlm.nih.gov

HPV self-collection: what are we waiting for? Exploration of attitudes from frontline healthcare providers. [2023]