ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 11 for:    Recruiting, Not yet recruiting, Available Studies | "Vaginal Smears"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03328013
Recruitment Status : Not yet recruiting
First Posted : November 1, 2017
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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.


Condition or disease
HPV Vaccination Pap Smear Cervical Cancer Catch-up Vaccination

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.


Study Type : Observational
Estimated Enrollment : 11700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Malvacdecision.Net
Estimated Study Start Date : November 2017
Estimated Primary Completion Date : November 2027
Estimated Study Completion Date : November 2027

Group/Cohort
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



Primary Outcome Measures :
  1. Nature of smear: normal or not (including ASCUS and AGC) according to their immunization status [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. age of occurrence of lesions according to the year of vaccination [ Time Frame: Day 1 (questionnaire completed by patient) ]
  2. number of injection received [ Time Frame: Day 1 (questionnaire completed by patient) ]
  3. Age of onset of sexual activit [ Time Frame: Day 1 (questionnaire completed by patient) ]
  4. Vaccine received [ Time Frame: Day 1 (questionnaire completed by patient) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 33 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328013


Contacts
Contact: Postec-Ollitrault Edith 02 98 22 39 4 edith.postec-ollitrault@chu-brest.fr

Locations
France
CHU de Brest Not yet recruiting
Brest, France, 29609
Contact: Postec-Ollitrault Edith       edith.postec-ollitrault@chu-brest.fr   
Sponsors and Collaborators
University Hospital, Brest

Additional Information:
Publications:

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03328013     History of Changes
Other Study ID Numbers: HPVAC (29BRC17.0086)
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female