Clinical trial · Observational
Clinical Evaluation of Detection of High Risk HPV in Urine
Clinical Evaluation Study of Urine hrHPV Detection for the Diagnosis of Presence of Cervical HPV and Correlation of Cervical Lesions
- 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 is one of the most common tumors in women, which seriously threatens women's life quality and safety. Human papilloma virus (HPV) infection is the most common cause of cervical cancer. Traditional HPV testing is based on the cells sample shed from the cervix. Recent studies have shown that urine HPV detection can be used as a new HPV detection method. This study intends to include patients undergoing TCT /HPV test/colposcopy in the department of gynecological diseases of the hospital, and collect urine samples and cervical swab samples. Sanger sequencing and cervical swab HPV test results were compared to evaluate the accuracy and clinical validity of urine HPV test combined with clinical diagnosis results of cases.
Conditions
Conditions (17)
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 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- HPV positive group
- label
- HPV negative group
- label
- Disease group (clinical diagnosis positive)
- description
- CIN2 and above disease cases, including HSIL or (CIN2, CIN2-3, CIN3) cervical cancer.
- label
- Control group (clinical diagnosis is negative)
- description
- includes other benign lesions such as inflammation, polyps, and HPV-negative cases without pathological diagnosis and no abnormalities in TCT.
Primary outcomes (1)
- measure
- Verification of accuracy
- timeFrame
- 2022/5
- description
- Consistency analysis of urine HPV test and Sanger sequencing results/cervical swab HPV test results The main evaluation indicators are the total test positive coincidence rate, total test negative coincidence rate, total coincidence rate, 16/18/other 12 types of positive and negative coincidence rates, kappa value and 95% confidence interval.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women aged 20-65 years old; 2. Have a history of sexual life; 3. The patients were voluntarily enrolled in the group and signed an informed consent form. Exclusion Criteria: 1. History of cervical conization, pelvic radiation and hysterectomy, acute inflammation of the reproductive tract, severe system disease or other malignant tumors; 2. Pregnant and lactating women; 3. The patient's compliance is poor or the researcher thinks it is not suitable for this study.
References
Publications (12)
- BACKGROUNDArbyn M, Castellsague X, de Sanjose S, Bruni L, Saraiya M, Bray F, Ferlay J. Worldwide burden of cervical cancer in 2008. Ann Oncol. 2011 Dec;22(12):2675-2686. doi: 10.1093/annonc/mdr015. Epub 2011 Apr 6. PMID 21471563
- BACKGROUNDSaxena U, Sauvaget C, Sankaranarayanan R. Evidence-based screening, early diagnosis and treatment strategy of cervical cancer for national policy in low- resource countries: example of India. Asian Pac J Cancer Prev. 2012;13(4):1699-703. doi: 10.7314/apjcp.2012.13.4.1699. PMID 22799391
- BACKGROUNDBosch FX, Lorincz A, Munoz N, Meijer CJ, Shah KV. The causal relation between human papillomavirus and cervical cancer. J Clin Pathol. 2002 Apr;55(4):244-65. doi: 10.1136/jcp.55.4.244. PMID 11919208
- BACKGROUNDWalboomers JM, Jacobs MV, Manos MM, Bosch FX, Kummer JA, Shah KV, Snijders PJ, Peto J, Meijer CJ, Munoz N. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999 Sep;189(1):12-9. doi: 10.1002/(SICI)1096-9896(199909)189:13.0.CO;2-F. PMID 10451482
- BACKGROUNDMunoz N, Bosch FX, de Sanjose S, Herrero R, Castellsague X, Shah KV, Snijders PJ, Meijer CJ; International Agency for Research on Cancer Multicenter Cervical Cancer Study Group. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med. 2003 Feb 6;348(6):518-27. doi: 10.1056/NEJMoa021641. PMID 12571259
- BACKGROUNDKhan MJ, Castle PE, Lorincz AT, Wacholder S, Sherman M, Scott DR, Rush BB, Glass AG, Schiffman M. The elevated 10-year risk of cervical precancer and cancer in women with human papillomavirus (HPV) type 16 or 18 and the possible utility of type-specific HPV testing in clinical practice. J Natl Cancer Inst. 2005 Jul 20;97(14):1072-9. doi: 10.1093/jnci/dji187. PMID 16030305
- BACKGROUNDzur Hausen H. Papillomaviruses in the causation of human cancers - a brief historical account. Virology. 2009 Feb 20;384(2):260-5. doi: 10.1016/j.virol.2008.11.046. Epub 2009 Jan 8.