Human Papillomavirus and Cervical Dysplasia in Women With Cystic Fibrosis

NCT ID: NCT03052556

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-08
• Study Completion Date: 2019-09-18

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Cohort of women with cystic fibrosis

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

Group Type: OTHER

Pap smear test and HPV test

Intervention Type: 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

Interventions

Pap smear test and HPV test

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vaincre la Mucoviscidose

OTHER

Sponsor Role: collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service de Gynécologie oncologique - Centre Hospitalier Lyon Sud

Pierre-Bénite, France, France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 36526553 (View on PubMed)

Other Identifiers

69HCL16_0703

Identifier Type: -

Identifier Source: org_study_id