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

November 27, 2009 updated by: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

6200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Knowledge of HPV and the link between HPV and cervical cancer
Time Frame: 5 years
5 years
Attitudes towards HPV vaccine
Time Frame: 5 years
5 years
Attitudes towards sex and the proper age of sexual debut;
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: You-lin Qiao, M.D. Ph.D., Cancer Hospital/Institute, Chinese Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

November 27, 2009

First Submitted That Met QC Criteria

November 27, 2009

First Posted (Estimate)

November 30, 2009

Study Record Updates

Last Update Posted (Estimate)

November 30, 2009

Last Update Submitted That Met QC Criteria

November 27, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 37207

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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