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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02895399
Other study ID # 30814
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Recruiting NCT05884697 - Let's K-Talk - HPV Study for Ethnic Koreans N/A
Recruiting NCT06223568 - Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal (Head and Neck) Cancer Phase 2