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

NCT02895399 | Completed

• 1 other identifier: 30814
• Study Type: observational
• Target: 643
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Human Papillomavirus Viruses

Outcome Measures

Primary Outcomes (1)

• Prevalence and distribution of Human Papillomaviruses genotypes

  At the time of inclusion (baseline)

Interventions

Cervico-Vaginal Smears analysis OTHER

Cervico-Vaginal Smears analysis

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

women from 20 to 65 years living on the Maroni and the Oyapock rivers having already had sexual intercourse

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier de Cayenne: lead

Biospecimen

Retention: SAMPLES WITH DNA

Cervico-Vaginal Smears

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: September 9, 2016
• Study Start: December 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: September 9, 2016

Record last verified: 2016-09