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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2009 by Chinese Academy of Medical Sciences
Sponsor:
Information provided by:
Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01021904
First received: November 27, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)
Intervention Details:
    Biological: Gardasil (VLP, HPV Quadrivalent prophylactic vaccine)
    0.5cc I/M Site deltoid Lt Rt 3-dose regimen: 0, 2, 6 months
Detailed 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.
  Eligibility

Ages Eligible for Study:   13 Years to 15 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01021904

Contacts
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

Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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:
Infection
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on November 19, 2014