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临床试验/NCT02895399
NCT02895399已完成不适用

Epidémiologie de l'Infection à Human Papilloma Virus Chez Les Femmes Vivant Sur Les Fleuves Maroni et Oyapock

Centre Hospitalier de Cayenne0 个研究点目标入组 643 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
643
主要终点
Prevalence and distribution of Human Papillomaviruses genotypes

研究概览

简要总结

Cervical cancer is the second most frequent cancer of women in French Guiana. Studies have shown that populations living in remote villages in the interior of the territory have early sexual relations and that multiple sexual partnerships are frequent. Hence, the main objective of the study was to determine the prevalence of HPV in these areas, and the predictive factors and epidemiology of this viral infection.

Methods - This multicentric cross sectional study aimed the population of women aged 20 to 65 years, living in the remote villages along the Maroni and Oyapock rivers. Women wishing to participate will be included after being informed of the study team schedule through radio address and key opinion leaders. The search for HPV and cytologic examinations will be performed for each woman. 2 samples will be taken from each woman: one sample will be sent to Fort De France hospital for cytology, and HPV testing; cytologic analyses will be performed using the 2001 Bethesda classification. Another sample will be sent to Pasteur Institute in Cayenne for sequencing and detection of E6 and E7 RNA which are associated with carcinogenesis. HPV infection will be defined by the detection of viral DNA using the GREINER-BIO-ONE kit. Statistical analysis of the results will use STATA software and mapping will use Mapinfo.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged from 20 to 65 living in a common Maroni rivers (Apatou , Grand Santi, Papaichton , Maripasoula and the Native American territory of Upper Maroni) and / or Oyapock ( Saint Georges, Camopi , Three Jumps )
  • Having already had sexual intercourse
  • Having given after information , consent to the inclusion in the study

排除标准

  • Age < 20 or age> 65 years
  • Being pregnant more than 3 months
  • Have had a hysterectomy
  • Denial of participation

结局指标

主要结局

Prevalence and distribution of Human Papillomaviruses genotypes

时间窗: At the time of inclusion (baseline)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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