Primary Cervical Cancer Screening by Self-sampling HPV Test

Cervical Cancer Clinical Trial

— PREVENT  

Official title:

Primary Cervical Cancer Screening by Self-sampling HPV Test

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05613283
• Other study ID #: NH-3004
• Status: Active, not recruiting
• Start date: November 19, 2022
• Est. completion date: August 31, 2027

Study information

• Verified date: December 2023
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 17875
• Est. completion date: August 31, 2027
• Est. primary completion date: July 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma in Situ
• Atypical Squamous Cells of Undetermined Significance
• Carcinoma in Situ
• Carcinoma, Squamous Cell
• Cervical Adenocarcinoma
• Cervical Cancer
• Cervical Intraepithelial Neoplasia Grade II
• Cervical Intraepithelial Neoplasia, Grade III
• Cervical Squamous Cell Carcinoma
• High-Grade Squamous Intraepithelial Lesions
• Human Papillomavirus Infection
• Low-Grade Squamous Intraepithelial Lesions
• Neoplasms
• Papillomavirus Infections
• Squamous Intraepithelial Lesions of the Cervix
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing
China	Hunan Provincial Maternal and Child Health Care Hospital	Changsha	Hunan
China	Chengdu Women's and Children's Central Hospital	Chengdu	Sichuan
China	Women's Hospital School Of Medicine Zhejiang University	Hangzhou	Zhejiang
China	Henan Cancer Hospital	Zhengzhou	Henan
China	The Third Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (3)

Lead Sponsor	Collaborator
Peking University People's Hospital	BeijingNewBiorayTechnologyCo.,Ltd., Hangzhou Newhorizon Health Technology Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (14)

???, ???, ???.14398????????????[J]. ??????,2021,30(16):2921-2923.

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. — View 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. — View 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. — View 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. — View 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

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2023/12
Primary	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.	2027/06