Clinical trial NCT03052556: Human Papillomavirus and Cervical Dysplasia in Women With Cystic Fibrosis
Official title: Prevalence and Persistence of Human Papillomavirus (HPV) and of Cervical Dysplasia in a Cohort of Women With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: cystic Fibrosis
cervical cancer
screening
human papilloma virus (HPV)
pap smear test
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: Vaincre la Mucoviscidose
First posted: 2017-02-14
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Background The main risk factor for cervical cancer is the infection by human papillomavirus (HPV), with several intermediate steps between HPV infection and cervical cancer. Cervical screening with pap smear test and HPV vaccination are effective preventions. A high frequency of HPV carriage and of cervical dysplasia have been described in transplanted women.

The majority of women with cystic fibrosis reach adulthood and some will face transplantation. Particular attention should therefore be paid to cervical screening. However, low adherence to screening recommendations was noted. In addition, preliminary data has found a high frequency of abnormal smears and of inflammatory aspect of the cervix in women with cystic fibrosis.

Objectives of the study The main objective of the study is to determine the prevalence of HPV carriage in a cohort of women with cystic fibrosis

The secondary objectives are:

* To study the factors associated with the prevalence of HPV (transplantation, smoking, age at first intercourse, number of sexual partners in the year, contraception, gravidity and parity, HPV vaccination)
* To describe and to compare with data in the general population, in hospital-based population, (and with data in transplanted population for transplanted women)

  1. the prevalence of HPV (and of different genotypes) infection, of cervical dysplasia, of vulvar/vaginal/cervical condylomatosis
  2. the rate of HPV persistence (\> 12 months), the mean time of HPV clearance; rates of spontaneous regression / persistence / worsening of cervical dysplasia

Study design:

The study will last 24 months. Includable patients are adult women, transplanted or not, followed at Lyon CRCM. Included women will attend a consultation with a gynaecologist. Pap smear test (liquid phase cytology) and genomic DNA microarray assay enabling the detection of 35 different HPV genotypes will be performed.

Patients with an initial abnormal pap smear or a positive HPV test will be monitored:

* In case of an abnormal smear and / or positive HPV test, pap smear and HPV testing will be renewed every 6 months during the study period
* In case of an abnormal smear:

Atypical squamous cells of undetermined significance (ASC-US) : the attitude will depend on the result of the HPV test Atypical squamous cells - cannot exclude HSI L (ASC-H), Low-grade squamous intraepithelial lesion (LSIL), High-grade squamous intraepithelial lesion (HSIL), Atypical glandular cell of undetermined significance (AGUS) , Atypical glandular cells (AGC) , Adenoma carcinoma in situ (AIS), carcinoma: a colposcopy will be systematically performed

Expected results This study will help to determine the frequency of HPV infection and the pathogenic power of HPV in non-transplanted and in transplanted women with cystic fibrosis This data will help to sensitize health professionals on the importance of gynecological care and regular cervical screening, and on the importance of HPV vaccination.

In case of a high frequency of genital diseases linked to HPV, recommendations on gynecological monitoring procedures for women with cystic fibrosis could evolve.


Eligibility criteria: Inclusion Criteria:

* Female with Cystic fibrosis
* Age 18 years or older
* transplanted or non-transplanted
* Accepting the principle of a gynecological consultation and the principle of follow-up every 6 months in case of abnormal smear or positive HPV test
* Patient covered by health insurance

Exclusion Criteria:

* Age under 18
* Refusal to participate in the study
* Patient under tutorship / curatorship

Primary outcomes:
measure: Prevalence of HPV carriage
timeFrame: day 0
Secondary outcomes:
measure: Rate of HPV persistence (> 12 months)
timeFrame: 12 months
measure: mean time of HPV clearance
timeFrame: 6 months, 12months, 18months and 24months
measure: Presence of factors associated with the prevalence of HPV
timeFrame: day 0
measure: Prevalence of cervical dysplasia or vulvar/vaginal/cervical condylomatosis
timeFrame: day 0
measure: Rate of spontaneous regression of cervical dysplasia
timeFrame: 12 months and 24 months
measure: Rate of persistence of cervical dysplasia
timeFrame: 12 months and 24 months
measure: Rate of worsening of cervical dysplasia
timeFrame: 12 months and 24 months
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Service de Gynécologie oncologique - Centre Hospitalier Lyon Sud
Study officials:
References: