Clinical trial · Observational
Primary Cervical Cancer Screening by Self-sampling HPV Test
NCT05613283CI-TRIAL-00072482PREVENTactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma in Situ | Adenocarcinoma In Situ | ONTOLOGY_EXACT | 0.98 |
| Atypical Glandular Cells | — | UNRESOLVED | — |
| Atypical Glandular Cells, Favor Neoplastic | — | UNRESOLVED | — |
| Atypical Squamous Cells, Cannot Rule Out High-grade Squamous Intraepithelial Lesion | — | UNRESOLVED | — |
| Atypical Squamous Cells of Undetermined Significance | — | UNRESOLVED | — |
| Cervical Adenocarcinoma | Cervical Adenocarcinoma | CURATED_BROADER | 0.80 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Intraepithelial Neoplasia Grade I | — | UNRESOLVED | — |
| Cervical Intraepithelial Neoplasia Grade II | — | UNRESOLVED |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Accuracy verification group
- description
- Assessment reagent urine sample HPV-PCR test result Assessment reagent vaginal secretion sample HPV-PCR test result Comparative Methods NGS Nucleic Acid Sequencing Results
- label
- Consistency verification group
- description
- 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
- label
- Efficacy and safety verification group
- description
- Thin-layer liquid-based cytology (TCT) results panel Colposcopy results Tissue biopsy pathological diagnosis result
Primary outcomes (2)
- measure
- Accuracy verification
- timeFrame
- 2023/12
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (14)
- BACKGROUNDNelson 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
- BACKGROUNDBruni 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
- BACKGROUNDWu 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
- BACKGROUNDBernal 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
- BACKGROUNDHagihara 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
- BACKGROUNDPathak 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
- BACKGROUNDCombita 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.