Human Papillomavirus and Cervical Dysplasia in Women With Cystic Fibrosis
Human Papillomavirus and Cervical Dysplasia in Women With Cystic Fibrosis
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.
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