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Human Papillomavirus InfectionPREVENTNCT05613283

Primary Cervical Cancer Screening by Self-sampling HPV Test

An observational study of Human Papillomavirus Infection and Cervical Cancer, run by Peking University People's Hospital at 6 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Cervical cancer seriously threatens women's health and HPV infection is the main cause of cervical cancer. Traditionally, Cervical cancer screening is based on cervical exfoliated cell samples collected by health care provider, which is labor consuming and the coverage and compliance are both relatively low in some… Read more about this study

Who is it for?
Ages 21 to 65 years, women onlyHealthy volunteers can take part
How many people
17,875 participants
Where
6 sitesChina
Study dates
19 Nov 2022to 31 Aug 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The population of clinical validity verification is all screening population, that is, women who need to undergo routine cervical cancer screening and the results of cervical cytology are unknown; Accuracy verification needs to include part of the screening population and part of the outpatient population, that is, women who intend or need to undergo colposcopy or cervical cancer screening for clinical visits.

Who may be able to join

  • a. Females aged 21-65; b. have a history of sexual life; c. The patients were voluntarily enrolled and signed the informed consent.

Who cannot join

  • Accuracy Verification:
  • Subjects meeting any of the following criteria will be excluded:
  • Known pregnant subjects.
  • Participants who have undergone total hysterectomy.
  • Participants who have received cervical resection therapy or ablative therapy within 12 months, such as cryo, laser, microwave, coagulation, cryotherapy, LEEP, large loop electrosurgery (LLETZ), cold knife conization (CKC), laser conization, or ablation.
  • Participants with poor compliance or researchers who believe that they are not suitable to participate in this study.
Show all 14Show fewer
  • Primary screening use:
  • Subjects meeting any of the following criteria will be excluded:
  • Known pregnant subjects.
  • Participants who have undergone total hysterectomy.
  • Participants who have received cervical resection therapy or ablative therapy within 12 months, such as cryo, laser, microwave, coagulation, cryotherapy, LEEP, large loop electrosurgery (LLETZ), cold knife conization (CKC), laser conization, or ablation.
  • Those with known history of cervical cancer.
  • Participants who participated in cervical cancer screening programs or underwent cervical cytology within 12 months.
  • Participants with poor compliance or researchers who believe that they are not suitable to participate in this study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Peking University People's Hospital

    Beijing, Beijing Municipality

  • Hunan Provincial Maternal and Child Health Care Hospital

    Changsha, Hunan

  • Chengdu Women's and Children's Central Hospital

    Chengdu, Sichuan

  • Women's Hospital School Of Medicine Zhejiang University

    Hangzhou, Zhejiang

  • Henan Cancer Hospital

    Zhengzhou, Henan

  • The Third Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Cervical cancer seriously threatens women's health and HPV infection is the main cause of cervical cancer. Traditionally, Cervical cancer screening is based on cervical exfoliated cell samples collected by health care provider, which is labor consuming and the coverage and compliance are both relatively low in some areas. Non-invasive hrHPV self-sampling test appears to be more acceptable and may improve the HPV screening coverage. This study aims to evaluate the clinical performance of a newly developed urine/vaginal self-sampling hrHPV test in Cervical cancer screening.

Read the detailed description

This study is a prospective multi-center clinical trial in China. Eligible participants are cervical cancer screening population who meet the enrollment criterias. All the participants are required to provide urine and vaginal samples by self-sampling, as well as the cervical exfoliated cell samples (by HCP). Participants may undergo colposcopy examination depending on the test results, and they will be followed up for three years.

The high-risk human papillomavirus nucleic acid detection kit (PCR-fluorescent probe method) developed by New Horizon Co., Ltd . is suitable for in vitro qualitative detection of 14 types of high-risk HPV ( 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) nucleic acid.

The clinical performance of the self-sampling test will be assessed base on the following outcomes:

  1. The sensitivity for detecting CIN2+
  2. The specificity in non-CIN2+ population
  3. The risk of developing CIN2+ in test positive cohort and test negative cohort
  4. The accuracy of detecting hrHPV
Keywords
Self-sampling HPV testing, Human papilloma virus, Cervical cancer
Medical subject headings
Papillomavirus Infections, Uterine Cervical Neoplasms, Atypical Squamous Cells of the Cervix, Squamous Intraepithelial Lesions, Uterine Cervical Dysplasia, Adenocarcinoma in Situ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05613283
Study groupRoleWhat they receive
Accuracy verification groupAssessment reagent urine sample HPV-PCR test result Assessment reagent vaginal secretion sample HPV-PCR test result Comparative Methods NGS Nucleic Acid Sequencing Results
Consistency verification groupAssessment reagent urine sample HPV-PCR test result Assessment reagent vaginal secretion sample HPV-PCR test result ApprovedListed Reagent Cervical Sample HPV-PCR Test Result
Efficacy and safety verification groupThin-layer liquid-based cytology (TCT) results panel Colposcopy results Tissue biopsy pathological diagnosis result

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy verification

    Calculate the positive coincidence rate, negative coincidence rate, total coincidence rate, and Kappa value of the comparison reagents and calculate the 95% confidence interval to verify the accuracy of detecting HPV infection.

    Measured: 2023/12

  2. Clinical validity verification

    The consistency of HPV detection of different sample types was analyzed, and the absolute risk value, relative risk value and 95% confidence interval of the development of ≥CIN2 in different primary screening types were calculated and used to verify the safety and effectiveness of the intended use of cervical cancer primary screening.

    Measured: 2027/06

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2022
  2. Study start19 Nov 2022
  3. Primary completionJul 2026 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
17,875 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05613283
Sponsor's protocol ID
NH-3004
Acronym
PREVENT
Status last verified
Dec 2023
First submitted
4 Nov 2022
Last updated
21 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Nelson EJ, Maynard BR, Loux T, Fatla J, Gordon R, Arnold LD. The acceptability of self-sampled screening for HPV DNA: a systematic review and meta-analysis. Sex Transm Infect. 2017 Feb;93(1):56-61. doi: 10.1136/sextrans-2016-052609. Epub 2016 Oct 19.

    PubMed 28100761

  • Bruni L, Albero G, Serrano B, et al.ICO/IARC Information Centre on HPV and Cancer (HPV Information Centre). Human Papillomavirus and Related Diseases in China. Summary Report 22 October 2021. [EB/OL].www.hpvcentre.net

  • Wu RF, Du H. [Development of model based on self-sampling HPV testing for cervical cancer screening]. Zhonghua Fu Chan Ke Za Zhi. 2017 Sep 25;52(9):582-585. doi: 10.3760/cma.j.issn.0529-567X.2017.09.002. No abstract available. Chinese.

    PubMed 28954445

  • Bernal S, Palomares JC, Artura A, Parra M, Cabezas JL, Robles A, Martin Mazuelos E. Comparison of urine and cervical samples for detecting human papillomavirus (HPV) with the Cobas 4800 HPV test. J Clin Virol. 2014 Dec;61(4):548-52. doi: 10.1016/j.jcv.2014.10.001. Epub 2014 Oct 12.

    PubMed 25453566

  • Hagihara M, Yamagishi Y, Izumi K, Miyazaki N, Suzuki T, Kato H, Nishiyama N, Koizumi Y, Suematsu H, Mikamo H. Comparison of initial stream urine samples and cervical samples for detection of human papillomavirus. J Infect Chemother. 2016 Aug;22(8):559-62. doi: 10.1016/j.jiac.2016.05.009. Epub 2016 Jun 21.

    PubMed 27342077

  • Pathak N, Dodds J, Zamora J, Khan K. Accuracy of urinary human papillomavirus testing for presence of cervical HPV: systematic review and meta-analysis. BMJ. 2014 Sep 16;349:g5264. doi: 10.1136/bmj.g5264.

    PubMed 25232064

  • Combita AL, Gheit T, Gonzalez P, Puerto D, Murillo RH, Montoya L, Vorsters A, Van Keer S, Van Damme P, Tommasino M, Hernandez-Suarez G, Sanchez L, Herrero R, Wiesner C. Comparison between Urine and Cervical Samples for HPV DNA Detection and Typing in Young Women in Colombia. Cancer Prev Res (Phila). 2016 Sep;9(9):766-71. doi: 10.1158/1940-6207.CAPR-16-0038. Epub 2016 Jul 14.

    PubMed 27417431

  • Cho HW, Shim SR, Lee JK, Hong JH. Accuracy of human papillomavirus tests on self-collected urine versus clinician-collected samples for the detection of cervical precancer: a systematic review and meta-analysis. J Gynecol Oncol. 2022 Jan;33(1):e4. doi: 10.3802/jgo.2022.33.e4. Epub 2021 Oct 7.

    PubMed 34783207

  • Arbyn M, Verdoodt F, Snijders PJ, Verhoef VM, Suonio E, Dillner L, Minozzi S, Bellisario C, Banzi R, Zhao FH, Hillemanns P, Anttila A. Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. Lancet Oncol. 2014 Feb;15(2):172-83. doi: 10.1016/S1470-2045(13)70570-9. Epub 2014 Jan 14.

    PubMed 24433684

  • Camara H, Zhang Y, Lafferty L, Vallely AJ, Guy R, Kelly-Hanku A. Self-collection for HPV-based cervical screening: a qualitative evidence meta-synthesis. BMC Public Health. 2021 Aug 4;21(1):1503. doi: 10.1186/s12889-021-11554-6.

    PubMed 34348689

  • Belinson JL, Wang G, Qu X, Du H, Shen J, Xu J, Zhong L, Yi J, Yi X, Wu R. The development and evaluation of a community based model for cervical cancer screening based on self-sampling. Gynecol Oncol. 2014 Mar;132(3):636-42. doi: 10.1016/j.ygyno.2014.01.006. Epub 2014 Jan 14.

    PubMed 24440471

  • Xu H, Yu Y, George W, Smith JS, Hu S, Dang L, Zhang X, Pan Q, Qiao Y, Zhao F. Comparison of the performance of paired urine and cervical samples for cervical cancer screening in screening population. J Med Virol. 2020 Feb;92(2):234-240. doi: 10.1002/jmv.25597. Epub 2019 Sep 30.

    PubMed 31535725

  • Belinson JL, Hu S, Niyazi M, Pretorius RG, Wang H, Wen C, Smith JS, Li J, Taddeo FJ, Burchette RJ, Qiao YL. Prevalence of type-specific human papillomavirus in endocervical, upper and lower vaginal, perineal and vaginal self-collected specimens: Implications for vaginal self-collection. Int J Cancer. 2010 Sep 1;127(5):1151-7. doi: 10.1002/ijc.25144.

    PubMed 20039323

  • 毛康娜, 刘艳欣, 陶惠芬.14398名妇女宫颈癌筛查结果分析[J]. 河南医学研究,2021,30(16):2921-2923.

Questions about this trial

What is this clinical trial studying?

An observational study of Human Papillomavirus Infection and Cervical Cancer, run by Peking University People's Hospital at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy verification (time frame: 2023/12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05613283, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.

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