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

Human Papillomavirus Viruses Clinical Trial

— EPHaVI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02895399
• Other study ID #: 30814
• Status: Completed
• Phase: N/A
• First received: September 5, 2016
• Last updated: September 8, 2016
• Start date: December 2012
• Est. completion date: October 2014

Study information

• Verified date: September 2016
• Source: Centre Hospitalier de Cayenne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: 'Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé'France: 'Commission nationale de l'informatique et des libertés'
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 643
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Human Papillomavirus Viruses
• Papillomavirus Infections

Intervention

Other:
• Cervico-Vaginal Smears analysis
Cervico-Vaginal Smears analysis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de Cayenne

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence and distribution of Human Papillomaviruses genotypes		At the time of inclusion (baseline)	No