Cervical Cancer Clinical Trial
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).
Status | Not yet recruiting |
Enrollment | 6200 |
Est. completion date | December 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 13 Years to 15 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Chinese Academy of Medical Sciences |
Bosch FX, Lorincz A, Muñoz N, Meijer CJ, Shah KV. The causal relation between human papillomavirus and cervical cancer. J Clin Pathol. 2002 Apr;55(4):244-65. Review. — View Citation
Cox JT. Epidemiology and natural history of HPV. J Fam Pract. 2006 Nov;Suppl:3-9. Review. — View Citation
Franco EL, Harper DM. Vaccination against human papillomavirus infection: a new paradigm in cervical cancer control. Vaccine. 2005 Mar 18;23(17-18):2388-94. Review. — View Citation
Muñoz N, Bosch FX, de Sanjosé S, Herrero R, Castellsagué X, Shah KV, Snijders PJ, Meijer CJ; International Agency for Research on Cancer Multicenter Cervical Cancer Study Group. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med. 2003 Feb 6;348(6):518-27. — View Citation
Muñoz N. Human papillomavirus and cancer: the epidemiological evidence. J Clin Virol. 2000 Oct;19(1-2):1-5. Review. — View Citation
Padel AF, Venning VA, Evans MF, Quantrill AM, Fleming KA. Human papillomaviruses in anogenital warts in children: typing by in situ hybridisation. BMJ. 1990 Jun 9;300(6738):1491-4. — View Citation
Qiao YL, Sellors JW, Eder PS, Bao YP, Lim JM, Zhao FH, Weigl B, Zhang WH, Peck RB, Li L, Chen F, Pan QJ, Lorincz AT. A new HPV-DNA test for cervical-cancer screening in developing regions: a cross-sectional study of clinical accuracy in rural China. Lancet Oncol. 2008 Oct;9(10):929-36. doi: 10.1016/S1470-2045(08)70210-9. Epub 2008 Sep 19. — View Citation
Schiffman M, Castle PE. Human papillomavirus: epidemiology and public health. Arch Pathol Lab Med. 2003 Aug;127(8):930-4. — View Citation
Sugase M, Moriyama S, Matsukura T. Human papillomavirus in exophytic condylomatous lesions on different female genital regions. J Med Virol. 1991 May;34(1):1-6. — View Citation
Trottier H, Franco EL. The epidemiology of genital human papillomavirus infection. Vaccine. 2006 Mar 30;24 Suppl 1:S1-15. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The quadrivalent HPV vaccine can prevent HPV naive girls at baseline from being infected at least on a five year follow-up and longer. | 5 years | Yes | |
Secondary | Knowledge of HPV and the link between HPV and cervical cancer | 5 years | No | |
Secondary | Attitudes towards HPV vaccine | 5 years | No | |
Secondary | Attitudes towards sex and the proper age of sexual debut; | 5 years | No |
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