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Prevaccination Study of Cervical Human Papillomavirus Types in Yangtze River Delta Area, 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 December 2011 by Xing Xie, MD, Zhejiang University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01487681
First Posted: December 7, 2011
Last Update Posted: December 7, 2011
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 (Responsible Party):
Xing Xie, MD, Zhejiang University
  Purpose

Human papilloma virus (HPV) infection contributes as a main causative factor to the development of invasive cervical cancer (ICC) and its precursors (cervical intraepithelial neoplasia, CIN). Currently, two prophylactic vaccines are employed for the prevention of genital HPV infection. As the prophylactic efficacy is type-restricted, determining the type-specific HPV distribution and their associations with ICC and its precursors would provide essential information in assessment of HPV vaccination program impact. The baseline information is also important for monitoring possible changes in type-specific HPV distribution after vaccination has been introduced.

Prevalence of HPV infection varies considerably across the world, and data were limited from less-developed countries. Knowledge of the detail pattern of HPV type-specific distribution in each region will be essential for public health policy decisions. This will also form the basis for determining which types should be included in future generation HPV vaccines targeted to specific regions.

While most studies were focus on ICC and high-grade cervical lesions, the association between HPV types and the progression of CIN1 has rarely been studied. CIN1 is an insensitive histopathological sign of HPV infection, most of which will spontaneously regress to normal with host immune system. However, some genotypes have been described as being more persistent and associated with progression from low-grade lesions to high-grade lesions, even ICC. Geographical data on type-specific prevalence of HPV in CIN1 with appropriately designed prospective studies would be helpful in identifying types preferentially associated with progression to malignancy and accurately predicting the future impact of vaccination in specific regions.

Free vaccination supported by the government appears to be unlikely at present in China. Thus, individuals need to pay the cost of vaccines for themselves presently. Yangtze River Delta Area is the most economically developed regions in China, and people here may become the largest vaccinated population at their own expense in China. To the best of the investigators knowledge, no multi-center study on HPV type-specific distribution and their associations with ICC and its precursors is available in Yangtze River Delta Area, China, which highlights the need for timely study in this region before large scale vaccination programs are carried out.


Condition
Human Papilloma Virus Cervical Cancer Cervical Intraepithelial Neoplasia

Study Type: Observational
Official Title: Prevaccination Distribution of Cervical Human Papillomavirus (HPV) Types and Their Associations With Invasive Cervical Cancer and Its Precursors in Yangtze River Delta Area, China

Resource links provided by NLM:


Further study details as provided by Xing Xie, MD, Zhejiang University:

Primary Outcome Measures:
  • Percentage of each HPV type in patients with invasive cervical cancer, cervical intraepithelial neoplasia 2-3 and cervical intraepithelial neoplasia 1, respectively, in Yangtze River Delta Area, China [ Time Frame: One year ]

Secondary Outcome Measures:
  • HPV types significantly associated with persistence or progression of cervical intraepithelial neoplasia 1 at one year in Yangtze River Delta Area, China [ Time Frame: One year ]

Biospecimen Retention:   Samples With DNA
The biospecimens are remainder tissue and exfoliated cervical cells of standard diagnosis and surgery.

Estimated Enrollment: 4000
Study Start Date: November 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Invasive cervical cancer
Cervical intraepithelial neoplasia 2/3
Cervical intraepithelial neoplasia 1

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with histologically confirmed CIN1, CIN2, CIN3 or invasive cervical cancer (ICC)
Criteria

Inclusion Criteria:

  • Women with histologically confirmed CIN1, CIN2, CIN3 or invasive cervical cancer (ICC)

Exclusion Criteria:

  • Women with a history of immunodeficiency disorders, including HIV, and those who had undergone chemoradiotherapy for cervical cancer were excluded.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01487681


Contacts
Contact: Xing Xie, Professor 86-571-87061501 xiex@mail.hz.zj.cn

Locations
China, Zhejiang
Women's hospital, School of medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Xing Xie, Professor    86-571-87061501    xiex@mail.hz.zj.cn   
Sponsors and Collaborators
Xing Xie, MD
Investigators
Study Director: Xing Xie, Professor Women's Hospital School Of Medicine Zhejiang University
  More Information

Responsible Party: Xing Xie, MD, Professor of Obstetrics and Gynecology,Director of Women's hospital, School of medicine, Zhejiang University, Zhejiang University
ClinicalTrials.gov Identifier: NCT01487681     History of Changes
Other Study ID Numbers: IISP 40192
First Submitted: November 30, 2011
First Posted: December 7, 2011
Last Update Posted: December 7, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Carcinoma in Situ
Papilloma
Cervical Intraepithelial Neoplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell


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