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OpenTrials
Completed

NCT Number: NCT02895399

Epidemiology of Human Papillomavirus Infection Among Women Living on the Maroni and the Oyapock Rivers

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.

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Key information

Age range

20 year–65 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Cervico-Vaginal Smears analysis

Other

Cervico-Vaginal Smears analysis

Primary outcomes

  1. Prevalence and distribution of Human Papillomaviruses genotypes

    Time frame: At the time of inclusion (baseline)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Cayenne

Other

Registry information

Official study title

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

Acronym: EPHaVI

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 9, 2016
Registry last updated
Sep 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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