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NCT03328013 Clinical Trial

Impact of HPV Vaccination to Catch up in the Emergence of Lesions of the Cervix

Cervical Cancer Clinical Trial

— HPVAC  

Official title:
Malvacdecision.Net

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03328013
Other study ID # HPVAC (29BRC17.0086)
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date December 4, 2017
Est. completion date October 19, 2021

Study information
Verified date October 2021
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In France, the vaccination coverage observed for HPV vaccination is low for a full-scale regimen, and has been falling since 2010. A high rate of HPV vaccination coverage has a significant epidemiological impact with a reduction in cervical cancer mortality. There is less data on vaccinated catch-up patients. In 2017, these patients are 25 years of age or older and carry out screening smears. The aim of this study is to demonstrate whether HPV catch-up vaccination results in a decrease in the abnormal smear rate compared to the rate in unvaccinated patients. If so, these data will help mobilize doctors to vaccinate patients against HPV, even in catching-up.

Description:

In France, the observed vaccination coverage is very low for a complete regimen and has been declining since 2010. This low coverage makes it impossible to benefit from the efficiency observed in the other countries. Indeed, a high HPV vaccination coverage rate would allow an epidemiologically significant impact with a reduction in cervical cancer mortality. In France, it is estimated that the vaccination of 80% of girls between the ages of 11 and 14 would reduce the incidence of 72% of CIN2 and 54% of CIN3. Nevertheless, there is less data on patients who have been vaccinated in catch-up. These patients are 25 years of age or older in 2017, and make smears. The aim of this study is to demonstrate whether HPV catch-up vaccination results in a decrease in the abnormal smear rate compared to the rate in unvaccinated patients. If our study shows the benefits of catch-up vaccination, these data will help to mobilize doctors to vaccinate girls 15-19 years of age against HPV if they have not been able to benefit between 11 and 14 years as recommended.

Recruitment information / eligibility
Status Terminated
Enrollment 191
Est. completion date October 19, 2021
Est. primary completion date October 19, 2021
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 33 Years
Eligibility Inclusion Criteria: - women - aged 25 to 33 in 2017 - with a smear analyzed at the Brest University Hospital Exclusion Criteria: - men - age over 33 years or less than 25 years - patient refusing to participate

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHU de Brest Brest

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

References & Publications (6)

Baudoin A, Sabiani L, Oundjian F, Tabouret E, Agostini A, Courbière B, Boubli L, Carcopino X. [HPV prophylactic vaccine coverage and factors impacting its practice among students and high school students in Marseilles' area]. J Gynecol Obstet Biol Reprod (Paris). 2015 Feb;44(2):126-35. doi: 10.1016/j.jgyn.2014.02.005. Epub 2014 Apr 2. French. — View Citation

Bouvret P, Mougin C, Prétet JL, Meurisse A, Bonnetain F, Fiteni F. [Practices and attitudes regarding HPV vaccination among general practitioners from Besançon]. J Gynecol Obstet Biol Reprod (Paris). 2016 Oct;45(8):972-978. doi: 10.1016/j.jgyn.2015.12.002. Epub 2016 Jan 15. French. — View Citation

Carcopino X, Camus C, Halfon P. [Diagnosis and clinical management of cervical HPV infections]. Presse Med. 2015 Jul-Aug;44(7-8):716-26. doi: 10.1016/j.lpm.2015.02.020. Epub 2015 Jun 9. Review. French. — View Citation

Doris B, Boyer L, Lavoué V, Riou F, Henno S, Tas P, Sévène L, Levêque J. [Cervical Pap smear in an epidemiologically exposed population: ideas, facts and arguments]. J Gynecol Obstet Biol Reprod (Paris). 2014 Jan;43(1):26-34. doi: 10.1016/j.jgyn.2013.11.012. Epub 2013 Dec 12. French. — View Citation

Riethmuller D, Ramanah R, Carcopino X, Levêque J. [The follow up of the women vaccinated against HPV]. J Gynecol Obstet Biol Reprod (Paris). 2013 Oct;42(6):525-33. doi: 10.1016/j.jgyn.2013.03.013. Epub 2013 May 10. Review. French. — View Citation

Wafo E, Ivorra-Deleuze D, Thuillier C, Rouzier R. [Evolution of the awareness of Human Papillomavirus (HPV) in the French population: Results of a telephonic inquiry]. J Gynecol Obstet Biol Reprod (Paris). 2010 Jun;39(4):305-9. doi: 10.1016/j.jgyn.2010.03.007. Epub 2010 Apr 28. French. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Nature of smear: normal or not (including ASCUS and AGC) according to their immunization status Day 1
Secondary age of occurrence of lesions according to the year of vaccination Day 1 (questionnaire completed by patient)
Secondary number of injection received Day 1 (questionnaire completed by patient)
Secondary Age of onset of sexual activity Day 1 (questionnaire completed by patient)
Secondary Vaccine received Day 1 (questionnaire completed by patient)
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