Human Papillomavirus and Cervical Dysplasia in Women With Cystic Fibrosis

NCT03052556 | Completed

• 1 other identifier: 69HCL16_0703
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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

Conditions

Cystic Fibrosis

Keywords

cystic Fibrosis; cervical cancer; screening; human papilloma virus (HPV); pap smear test

Outcome Measures

Primary Outcomes (1)

• Prevalence of HPV carriage

  Genomic DNA microarray assay enabling the detection of 35 different HPV genotypes will be performed.

  day 0

Secondary Outcomes (7)

• Rate of HPV persistence (> 12 months)

  12 months

• mean time of HPV clearance

  6 months, 12months, 18months and 24months

• Presence of factors associated with the prevalence of HPV

  day 0

• Prevalence of cervical dysplasia or vulvar/vaginal/cervical condylomatosis

  day 0

• Rate of spontaneous regression of cervical dysplasia

  12 months and 24 months

Study Arms (1)

Cohort of women with cystic fibrosis

OTHER

Includable patients are adult women, transplanted or not, followed at Lyon CRCM (Centre de Ressources et de Compétences de la Mucoviscidose).

Procedure: Pap smear test and HPV test

Interventions

Pap smear test and HPV test PROCEDURE

Included women will attend a consultation with a gynaecologist. Pap smear test with HPV test will be performed. Samples collected by cervical scrape with a brush, will be prepared for liquid-based cytology. A sample of the sample will be used for research on HPV (Multiplex DNA PCR). This method allows detection of 35 different HPV genotypes: high risk (HPV-16, -18, -26, -31, -33, -35, -39, -45, -51, -52, 53, -56, -58, -59, -66, -68, -70, -73, -82, and -85); and low risk (HPV-6, -11, -40, -42, -43, -44, -54, -61, -62, -71, -72, -81, -83, -84, and -89). 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: ASC-US: the attitude will depend on the result of the HPV test ASC-H, LSIL, HSIL, AGUS, AGC, AIS, carcinoma: a colposcopy will be performed

Cohort of women with cystic fibrosis

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead
• Vaincre la Mucoviscidose: collaborator

Study Sites (1)

Service de Gynécologie oncologique - Centre Hospitalier Lyon Sud

Pierre-Bénite, France, 69310, France

Location

Related Publications (1)

• Rousset-Jablonski C, Mekki Y, Denis A, Reynaud Q, Nove-Josserand R, Durupt S, Touzet S, Perceval M, Ray-Coquard I, Golfier F, Durieu I. Human papillomavirus prevalence, persistence and cervical dysplasia in females with cystic fibrosis. J Cyst Fibros. 2023 May;22(3):505-514. doi: 10.1016/j.jcf.2022.11.005. Epub 2022 Dec 14.

  PMID: 36526553 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 14, 2017
• Study Start: March 8, 2017
• Primary Completion: September 18, 2019
• Study Completion: September 18, 2019
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)