Clinical trial NCT05613283: Primary Cervical Cancer Screening by Self-sampling HPV Test
Official title: Primary Cervical Cancer Screening by Self-sampling HPV Test
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Human Papillomavirus Infection
Cervical Cancer
Negative For Intraepithelial Lesion Or Malignancy
Atypical Squamous Cells of Undetermined Significance
Atypical Squamous Cells, Cannot Rule Out High-grade Squamous Intraepithelial Lesion
Cervical Squamous Intraepithelial Lesion
Low-Grade Squamous Intraepithelial Lesions
High-Grade Squamous Intraepithelial Lesions
Cervical Intraepithelial Neoplasia Grade I
Cervical Intraepithelial Neoplasia Grade II
Cervical Intraepithelial Neoplasia, Grade III
Atypical Glandular Cells
Atypical Glandular Cells Not Otherwise Specified
Atypical Glandular Cells, Favor Neoplastic
Cervical Squamous Cell Carcinoma
Adenocarcinoma in Situ
Cervical Adenocarcinoma
Keywords: Self-sampling HPV testing
Human papilloma virus
Cervical cancer
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: BeijingNewBiorayTechnologyCo.,Ltd.
name: Hangzhou Newhorizon Health Technology Co., Ltd.
First posted: 2022-11-14
Enrollment: 17875
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Accuracy Verification:

Subjects meeting any of the following criteria will be excluded:

1. Known pregnant subjects.
2. Participants who have undergone total hysterectomy.
3. 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.
4. Participants with poor compliance or researchers who believe that they are not suitable to participate in this study.

   * Primary screening use:

Subjects meeting any of the following criteria will be excluded:

1. Known pregnant subjects.
2. Participants who have undergone total hysterectomy.
3. 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.
4. Those with known history of cervical cancer.
5. Participants who participated in cervical cancer screening programs or underwent cervical cytology within 12 months.
6. Participants with poor compliance or researchers who believe that they are not suitable to participate in this study.

Primary outcomes:
measure: Accuracy verification
timeFrame: 2023/12
measure: Clinical validity verification
timeFrame: 2027/06
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The Third Affiliated Hospital of Zhengzhou University
state: Henan
city: Changsha
country: China
facility: Hunan Provincial Maternal and Child Health Care Hospital
state: Hunan
city: Chengdu
country: China
facility: Chengdu Women's and Children's Central Hospital
state: Sichuan
city: Hangzhou
country: China
facility: Women's Hospital School Of Medicine Zhejiang University
state: Zhejiang
Study officials:
References:
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.