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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2009 by Chinese Academy of Medical Sciences.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01021904
First Posted: November 30, 2009
Last Update Posted: November 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Chinese Academy of Medical Sciences
November 27, 2009
November 30, 2009
November 30, 2009
June 2010
June 2014   (Final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
  • Knowledge of HPV and the link between HPV and cervical cancer [ Time Frame: 5 years ]
  • Attitudes towards HPV vaccine [ Time Frame: 5 years ]
  • Attitudes towards sex and the proper age of sexual debut; [ Time Frame: 5 years ]
Same as current
Not Provided
Not Provided
 
Primary and Secondary Prevention of Human Papillomavirus (HPV) Disease in China
Not Provided

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).

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.
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • HPV Infections
  • Precancerous Disease of the Cervix
  • Cervical Cancer
  • HPV Related Diseases
Biological: Gardasil (VLP, HPV Quadrivalent prophylactic vaccine)
0.5cc I/M Site deltoid Lt Rt 3-dose regimen: 0, 2, 6 months
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
6200
December 2014
June 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
13 Years to 15 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01021904
37207
Yes
Not Provided
Not Provided
You-Lin Qiao, M.D, Ph.D. Professor and Chief, Dept of Cancer Epidemiology, Cancer Hospital/Institute, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
Not Provided
Principal Investigator: You-lin Qiao, M.D. Ph.D. Cancer Hospital/Institute, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP