Primary and Secondary Prevention of Human Papillomavirus (HPV) Disease in China

Cervical Cancer Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01021904
• Other study ID #: 37207
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 27, 2009
• Last updated: November 27, 2009
• Start date: June 2010
• Est. completion date: December 2014

Study information

• Verified date: November 2009
• Source: Chinese Academy of Medical Sciences
• Contact: You-Lin Qiao, Ph.D
• Phone: +86-10-8778-8489
• Email: Qiaoy[@]cicams.ac.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

In a hospital-based multi-center study in China, HPV 16 was found to be the predominant type (72.9%) in cervical cancer, followed by HPV 18(8.0%) which indicated that if the HPV prophylactic vaccine are wisely applied in China, about 80% of cervical cancer can be prevented.The reported prevalence of HPV in the female population in China was about 13.2%, with women in the study between ages 15-55. HPV prevalence peaks in young adults (ages 20-24:15.5%) and pre-menopausal women (ages 45-49:15%) and this suggests an underestimation of cervical cancer burden in China.

So far, there is no nation wide organized screening program in China, nor is the vaccine available for girls innocent to HPV infection. This study aims to vaccinate the daughters (aged between 13-15 yrs) living in the selected study areas thus to evaluate how cervical cancer and other HPV related diseases can be curbed through primary and secondary prevention(in company to screening the mothers aged 35-54 yrs) and to develop a China specific model for cervical cancer prevention through HPV vaccination and HPV DNA test (careHPV).

Description:

Selection of Vaccination age group

-It is well acknowledged that preadolescent or adolescent girls before their sexual debut will benefit the most from HPV vaccination. According to our previous study conducted in year 2007, the median age of sexual debut in Xinjiang was 17 years old (95% CI: 14-21). Data on the age of sexual debut in the other two identified regions is not available and we made an approximate estimation according to our data previously collected from other parts of China.From these data, we don't see an obvious time trend of sexual debut age from other parts of China and the majority of girls became sexually active after 15 years old. We thus suggest coverage of 13-15 years old girls for HPV vaccination in our identified regions.

Goal of this Program

-The purpose of this program is to implement and evaluate what it takes to establish and operate a public health program on cervical cancer prevention by vaccination and early detection treatment program in resource restricted selected autonomous regions of China. The learnings on how to implement such projects and the costing of the interventions and program will be useful for national policy planners and regional authorities when they consider future health priorities and allocation of resources.

Objectives

The objectives of the pilot program are to:

1. Develop a communication and education program on cervical cancer for families in the target area and try to deliver the message of 'Vaccinate the daughters and screen the mothers' to curb cervical cancer.

2. Develop a China specific model for cervical cancer prevention through HPV vaccination and HPV DNA test ( careHPV).

3. Capacitate the health facilities in the selected counties in each region to conduct HPV vaccination, screen for cervical cancer and treat precancerous lesions and cervical cancer.

4. Develop a referral system for advanced cases of cervical cancer that cannot be treated at lower level facilities

5. Develop training guidelines and supportive management systems for all levels of the health care system and cost all interventions for policy purposes.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6200
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 15 Years

Eligibility

Inclusion Criteria:

• Long term residence in the selected study areas (at least more than 5 years from the beginning of the study)

• aged between 13-15 yrs

• With complete cervix

• Not sexually active

• Physically competent to undergo vaccination

• With ability to provide informed consent

Exclusion Criteria:

• Short term residence (less than 5 years from the beginning of the study)

• Dose not have a cervix

• Physically incompetent to undergo vaccination

• With no ability to provide informed consent

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cervical Cancer
• HPV Infections
• HPV Related Diseases
• Precancerous Disease of the Cervix
• Uterine Cervical Neoplasms

Intervention

Biological:
• Gardasil (VLP, HPV Quadrivalent prophylactic vaccine)
0.5cc I/M Site deltoid Lt Rt 3-dose regimen: 0, 2, 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

References & Publications (10)

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

Cox JT. Epidemiology and natural history of HPV. J Fam Pract. 2006 Nov;Suppl:3-9. Review. — View Citation

Franco EL, Harper DM. Vaccination against human papillomavirus infection: a new paradigm in cervical cancer control. Vaccine. 2005 Mar 18;23(17-18):2388-94. Review. — 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

Muñoz N. Human papillomavirus and cancer: the epidemiological evidence. J Clin Virol. 2000 Oct;19(1-2):1-5. Review. — View Citation

Padel AF, Venning VA, Evans MF, Quantrill AM, Fleming KA. Human papillomaviruses in anogenital warts in children: typing by in situ hybridisation. BMJ. 1990 Jun 9;300(6738):1491-4. — View Citation

Qiao YL, Sellors JW, Eder PS, Bao YP, Lim JM, Zhao FH, Weigl B, Zhang WH, Peck RB, Li L, Chen F, Pan QJ, Lorincz AT. A new HPV-DNA test for cervical-cancer screening in developing regions: a cross-sectional study of clinical accuracy in rural China. Lancet Oncol. 2008 Oct;9(10):929-36. doi: 10.1016/S1470-2045(08)70210-9. Epub 2008 Sep 19. — View Citation

Schiffman M, Castle PE. Human papillomavirus: epidemiology and public health. Arch Pathol Lab Med. 2003 Aug;127(8):930-4. — View Citation

Sugase M, Moriyama S, Matsukura T. Human papillomavirus in exophytic condylomatous lesions on different female genital regions. J Med Virol. 1991 May;34(1):1-6. — View Citation

Trottier H, Franco EL. The epidemiology of genital human papillomavirus infection. Vaccine. 2006 Mar 30;24 Suppl 1:S1-15. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The quadrivalent HPV vaccine can prevent HPV naive girls at baseline from being infected at least on a five year follow-up and longer.		5 years	Yes
Secondary	Knowledge of HPV and the link between HPV and cervical cancer		5 years	No
Secondary	Attitudes towards HPV vaccine		5 years	No
Secondary	Attitudes towards sex and the proper age of sexual debut;		5 years	No