Clinical Evaluation of Detection of High Risk HPV in Urine

Cervical Cancer Clinical Trial

— Urine-hrHPV  

Official title:

Clinical Evaluation Study of Urine hrHPV Detection for the Diagnosis of Presence of Cervical HPV and Correlation of Cervical Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05210348
• Other study ID #: Urine-hrHPV 2021
• Status: Recruiting
• Start date: September 15, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: December 2021
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The urine high-risk HPV detection reagent (PCR-fluorescent probe method) developed by Hangzhou Newhorizon Health Technology Co., Ltd. can qualitatively detect 14 high-risk HPV DNA in human urine samples, including HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68, and can detect HPV 16 and 18.

This test adopts the comparative clinical research method, by collecting urine samples and cervical swab samples from the same subject for HPV nucleic acid detection. Among them, urine samples were tested for high-risk HPV nucleic acid testing and Sanger sequencing, and cervical swab samples were tested with HPV testing kits for cervical swabs that have been on the market. Combined with the clinical diagnosis results of the cases, the performance of the urine HPV detection technology is compared and evaluated.

For patients undergoing TCT testing/HPV testing/colposcopy in the gynecological clinic or colposcopy clinic of the hospital, the subjects will be screened through the admission criteria and signed an informed consent; the examiner is required to collect cervical swab samples and, at the same time, issue urine collection When the tube is given to the subject, the subject must collect urine samples by themselves according to the sampling instructions or under the guidance of medical personnel; the patient samples will be tested by Hangzhou Newhorizon Health Technology Co., Ltd.; the clinical examination report will be collected as the case materials of this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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.

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
• Cervical Intraepithelial Neoplasia Grade II
• Cervical Intraepithelial Neoplasia, Grade III
• Cervical Squamous Cell Carcinoma
• High-Grade Squamous Intraepithelial Lesions
• Human Papilloma Virus
• Human Papillomavirus Infection
• Low-grade Squamous Intraepithelial Lesion
• Neoplasms
• Papilloma
• Papillomavirus Infections
• Squamous Intraepithelial Lesions of the Cervix
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing
China	Nanjing First Hospital	Nanjing	Jiangsu
China	The Third Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (4)

Lead Sponsor	Collaborator
Peking University People's Hospital	Beijing Tsingke Biological Technology Co., Ltd. Hangzhou Branch, Hangzhou Mingze Medical Research Co., Ltd., Hangzhou Newhorizon Health Technology Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (12)

Arbyn M, Castellsagué X, de Sanjosé 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. — View Citation

Bernal S, Palomares JC, Artura A, Parra M, Cabezas JL, Robles A, Martín 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

Bosch FX, Lorincz A, Muñoz N, Meijer CJ, Shah KV. The causal relation between human papillomavirus and cervical cancer. J Clin Pathol. 2002 Apr;55(4):244-65. Review. — View Citation

Cómbita AL, Gheit T, González P, Puerto D, Murillo RH, Montoya L, Vorsters A, Van Keer S, Van Damme P, Tommasino M, Hernández-Suárez G, Sánchez 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

Khan 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. — View Citation

Muñoz N, Bosch FX, de Sanjosé S, Herrero R, Castellsagué 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. — 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. Review. — View Citation

Pinto AP, Crum CP. Natural history of cervical neoplasia: defining progression and its consequence. Clin Obstet Gynecol. 2000 Jun;43(2):352-62. Review. — View Citation

Saxena 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. Review. — View Citation

Walboomers JM, Jacobs MV, Manos MM, Bosch FX, Kummer JA, Shah KV, Snijders PJ, Peto J, Meijer CJ, Muñoz N. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999 Sep;189(1):12-9. — View Citation

zur 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. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical validity verification	Using the clinical diagnosis result (colposcopy or pathology report) of the case as the gold standard, evaluate the sensitivity, specificity and the corresponding 95% confidence interval, etc. of the HPV detection of urine samples and cervical swab samples for cervical intraepithelial neoplasia grade II and above (=CIN2)	2022/5

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