Primary and Secondary Prevention of Human Papillomavirus (HPV) Disease in China
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
HPV Infections Precancerous Disease of the Cervix Cervical Cancer HPV Related Diseases |
Biological: Gardasil (VLP, HPV Quadrivalent prophylactic vaccine) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
- The quadrivalent HPV vaccine can prevent HPV naive girls at baseline from being infected at least on a five year follow-up and longer. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Knowledge of HPV and the link between HPV and cervical cancer [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Attitudes towards HPV vaccine [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Attitudes towards sex and the proper age of sexual debut; [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 6200 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
-
Biological: Gardasil (VLP, HPV Quadrivalent prophylactic vaccine)
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:
- 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.
- Develop a China specific model for cervical cancer prevention through HPV vaccination and HPV DNA test ( careHPV).
- 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.
- Develop a referral system for advanced cases of cervical cancer that cannot be treated at lower level facilities
- Develop training guidelines and supportive management systems for all levels of the health care system and cost all interventions for policy purposes.
Eligibility| Ages Eligible for Study: | 13 Years to 15 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: You-Lin Qiao, Ph.D | +86-10-8778-8489 | Qiaoy@cicams.ac.cn |
| Contact: Jing Li, M.D. M.Sc | 86-10-8778-8942 | leej@cicams.ac.cn |
| Principal Investigator: | You-lin Qiao, M.D. Ph.D. | Cancer Hospital/Institute, Chinese Academy of Medical Sciences |
More Information
Publications:
| Responsible Party: | You-Lin Qiao, M.D, Ph.D. Professor and Chief, Dept of Cancer Epidemiology, Cancer Hospital/Institute, Chinese Academy of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01021904 History of Changes |
| Other Study ID Numbers: | 37207 |
| Study First Received: | November 27, 2009 |
| Last Updated: | November 27, 2009 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Chinese Academy of Medical Sciences:
|
Primary prevention HPV Vaccination HPV Infection Cervical Cancer HPV Related Diseases |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 23, 2013