Clinical trial NCT03328013: Impact of HPV Vaccination to Catch up in the Emergence of Lesions of the Cervix
Official title: Malvacdecision.Net
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: HPV Vaccination
Pap Smear
Cervical Cancer
Catch-up Vaccination
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 191
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 33
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women, aged 25 to 33 in 2017, with a smear analyzed at the Brest University Hospital, vaccinated or not against HPV

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Nature of smear: normal or not (including ASCUS and AGC) according to their immunization status
timeFrame: Day 1
Secondary outcomes:
measure: age of occurrence of lesions according to the year of vaccination
timeFrame: Day 1 (questionnaire completed by patient)
measure: number of injection received
timeFrame: Day 1 (questionnaire completed by patient)
measure: Age of onset of sexual activity
timeFrame: Day 1 (questionnaire completed by patient)
measure: Vaccine received
timeFrame: Day 1 (questionnaire completed by patient)
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
Study officials:
References:
citation: Baudoin A, Sabiani L, Oundjian F, Tabouret E, Agostini A, Courbiere 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.
citation: Doris B, Boyer L, Lavoue V, Riou F, Henno S, Tas P, Sevene L, Leveque 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.
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. No abstract available. French.
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.
citation: Bouvret P, Mougin C, Pretet JL, Meurisse A, Bonnetain F, Fiteni F. [Practices and attitudes regarding HPV vaccination among general practitioners from Besancon]. 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.
citation: Riethmuller D, Ramanah R, Carcopino X, Leveque 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. French.