Primary Cervical Cancer Screening by Self-sampling HPV Test

NCT05613283 | Active Not Recruiting

• 1 other identifier: NH-3004
• Study Type: observational
• Target: 17,875
• Locations: 1 country
• Sites: 6

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Accuracy verification group

Assessment 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 group

Assessment 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 group

Thin-layer liquid-based cytology (TCT) results panel Colposcopy results Tissue biopsy pathological diagnosis result

Eligibility Criteria

• Age: 21 Years - 65 Years
• Gender Eligibility Details: Based on biological sex
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• BeijingNewBiorayTechnologyCo.,Ltd.: collaborator
• Hangzhou Newhorizon Health Technology Co., Ltd.: collaborator

Study Sites (6)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

The Third Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Hunan Provincial Maternal and Child Health Care Hospital

Changsha, Hunan, China

Location

Chengdu Women's and Children's Central Hospital

Chengdu, Sichuan, China

Location

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Location

Related Publications (14)

• 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.

  PMID: 28100761 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 28954445 BACKGROUND

• 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.

  PMID: 25453566 BACKGROUND

• 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.

  PMID: 27342077 BACKGROUND

• 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.

  PMID: 25232064 BACKGROUND

• 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.

  PMID: 27417431 BACKGROUND

• 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.

  PMID: 34783207 BACKGROUND

• 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.

  PMID: 24433684 BACKGROUND

• 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.

  PMID: 34348689 BACKGROUND

• 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.

  PMID: 24440471 BACKGROUND

• 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.

  PMID: 31535725 BACKGROUND

• 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.

  PMID: 20039323 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms; Atypical Squamous Cells of the Cervix; Squamous Intraepithelial Lesions; Uterine Cervical Dysplasia; Adenocarcinoma in Situ

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Precancerous Conditions; Morphological and Microscopic Findings; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma in Situ

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 14, 2022
• Study Start: November 19, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: December 21, 2023

Record last verified: 2023-12

Locations

CN (6)