NCT03328013

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
191

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

December 4, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2021

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

3.9 years

First QC Date

October 18, 2017

Last Update Submit

October 19, 2021

Conditions

HPV VaccinationPap SmearCervical CancerCatch-up Vaccination

Outcome Measures

Primary Outcomes (1)

  • Nature of smear: normal or not (including ASCUS and AGC) according to their immunization status

    Day 1

Secondary Outcomes (4)

  • age of occurrence of lesions according to the year of vaccination

    Day 1 (questionnaire completed by patient)

  • number of injection received

    Day 1 (questionnaire completed by patient)

  • Age of onset of sexual activity

    Day 1 (questionnaire completed by patient)

  • Vaccine received

    Day 1 (questionnaire completed by patient)

Study Arms (1)

Women aged 25 to 33 years in 2017

Women aged 25 to 33 years in 2017 and having performed an analyzed smear at the Brest University Hospital. They are invited to fill out an online questionnaire asking them about : * vaccine status against HPV * if vaccinated, the name of the vaccine and the number of injection * age of first sexual intercourse * do they have a gynecological pathology

Eligibility Criteria

Age25 Years - 33 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • women
  • aged 25 to 33 in 2017
  • with a smear analyzed at the Brest University Hospital

You may not qualify if:

  • men
  • age over 33 years or less than 25 years
  • patient refusing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Brest

Brest, 29609, France

Location

Related Publications (6)

  • 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.

    PMID: 24703591BACKGROUND

  • 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.

    PMID: 24332738BACKGROUND

  • 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.

    PMID: 26067573BACKGROUND

  • 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.

    PMID: 20430535BACKGROUND

  • 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.

    PMID: 26780841BACKGROUND

  • 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.

    PMID: 23669416BACKGROUND

Related Links

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2017

First Posted

November 1, 2017

Study Start

December 4, 2017

Primary Completion

October 19, 2021

Study Completion

October 19, 2021

Last Updated

October 26, 2021

Record last verified: 2021-10

Locations

FR(1)