Clinical Evaluation of Detection of High Risk HPV in Urine
Urine-hrHPV
Clinical Evaluation Study of Urine hrHPV Detection for the Diagnosis of Presence of Cervical HPV and Correlation of Cervical Lesions
1 other identifier
observational
1,000
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2021
CompletedFirst Submitted
Initial submission to the registry
January 7, 2022
CompletedFirst Posted
Study publicly available on registry
January 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedJanuary 27, 2022
December 1, 2021
5 months
January 7, 2022
January 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Verification of accuracy
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.
2022/5
Secondary Outcomes (1)
Clinical validity verification
2022/5
Study Arms (4)
HPV positive group
HPV negative group
Disease group (clinical diagnosis positive)
CIN2 and above disease cases, including HSIL or (CIN2, CIN2-3, CIN3) cervical cancer.
Control group (clinical diagnosis is negative)
includes other benign lesions such as inflammation, polyps, and HPV-negative cases without pathological diagnosis and no abnormalities in TCT.
Eligibility Criteria
Patients undergoing TCT/HPV/colposcopy in the gynecological clinic or colposcopy clinic of the hospital
You may qualify if:
- Women aged 20-65 years old;
- Have a history of sexual life;
- The patients were voluntarily enrolled in the group and signed an informed consent form.
You may not qualify if:
- History of cervical conization, pelvic radiation and hysterectomy, acute inflammation of the reproductive tract, severe system disease or other malignant tumors;
- Pregnant and lactating women;
- The patient's compliance is poor or the researcher thinks it is not suitable for this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Peking University People's Hospital
Beijing, Beijing Municipality, China
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Related Publications (12)
Arbyn 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: 21471563BACKGROUNDSaxena 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: 22799391BACKGROUNDBosch 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: 11919208BACKGROUNDWalboomers 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: 10451482BACKGROUNDMunoz 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: 12571259BACKGROUNDKhan 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: 16030305BACKGROUNDzur 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.
PMID: 19135222BACKGROUNDPinto AP, Crum CP. Natural history of cervical neoplasia: defining progression and its consequence. Clin Obstet Gynecol. 2000 Jun;43(2):352-62. doi: 10.1097/00003081-200006000-00015. No abstract available.
PMID: 10863633BACKGROUNDBernal 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: 25453566BACKGROUNDHagihara 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: 27342077BACKGROUNDPathak 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: 25232064BACKGROUNDCombita 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: 27417431BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief physician
Study Record Dates
First Submitted
January 7, 2022
First Posted
January 27, 2022
Study Start
September 15, 2021
Primary Completion
February 1, 2022
Study Completion
May 1, 2022
Last Updated
January 27, 2022
Record last verified: 2021-12