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Human Papillomavirus and Cervical Dysplasia in Women With Cystic Fibrosis (MUCOHPV)

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ClinicalTrials.gov Identifier: NCT03052556
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : February 23, 2018
Sponsor:
Collaborator:
Vaincre la Mucoviscidose
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Procedure: Pap smear test and HPV test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Prevalence and Persistence of Human Papillomavirus (HPV) and of Cervical Dysplasia in a Cohort of Women With Cystic Fibrosis
Actual Study Start Date : March 8, 2017
Estimated Primary Completion Date : December 8, 2019
Estimated Study Completion Date : December 8, 2019


Arm Intervention/treatment
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).
Procedure: 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





Primary Outcome Measures :
  1. Prevalence of HPV carriage [ Time Frame: day 0 ]
    Genomic DNA microarray assay enabling the detection of 35 different HPV genotypes will be performed.


Secondary Outcome Measures :
  1. Rate of HPV persistence (> 12 months) [ Time Frame: 12 months ]
    In case of a HPV positive test at inclusion, HPV tests will be repeated every 6 months during the study.

  2. mean time of HPV clearance [ Time Frame: 6 months, 12months, 18months and 24months ]
    In case of a HPV positive test at inclusion, HPV tests will be repeated every 6 months during the study.

  3. Presence of factors associated with the prevalence of HPV [ Time Frame: day 0 ]
    factors studied are : transplantation, smoking, age at first intercourse, number of sexual partners in the year, contraception, gravidity and parity, HPV vaccination

  4. Prevalence of cervical dysplasia or vulvar/vaginal/cervical condylomatosis [ Time Frame: day 0 ]
    Gynecological clinical examination with pap smear test will be performed at inclusion. The Bethesda system will be used for reporting Pap smear results. In case of abnormal pap smear, a colposcopy will be performed, with biopsies if indicated.

  5. Rate of spontaneous regression of cervical dysplasia [ Time Frame: 12 months and 24 months ]
    In case of high cervical dysplasia, usual recommended management will be executed. In case of low grade dysplasia (with concordant pap smear test and satisfactory colposcopy), a follow-up by colposcopy/biopsy will be performed every 6 months during the study

  6. Rate of persistence of cervical dysplasia [ Time Frame: 12 months and 24 months ]
    In case of high cervical dysplasia, usual recommended management will be executed. In case of low grade dysplasia (with concordant pap smear test and satisfactory colposcopy), a follow-up by colposcopy/biopsy will be performed every 6 months during the study

  7. Rate of worsening of cervical dysplasia [ Time Frame: 12 months and 24 months ]
    In case of high cervical dysplasia, usual recommended management will be executed. In case of low grade dysplasia (with concordant pap smear test and satisfactory colposcopy), a follow-up by colposcopy/biopsy will be performed every 6 months during the study



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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): NCT03052556


Contacts
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Contact: Christine ROUSSET-JABLONSKI, MD (0)4 78 56 90 49 ext +33 christine.rousset-jablonski@chu-lyon.fr
Contact: Sandrine TOUZET, MD (0)4 72 11 57 61 ext +33 sandrine.touzet@chu-lyon.fr

Locations
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France
Service de Gynécologie oncologique - Centre Hospitalier Lyon Sud Recruiting
Pierre-Bénite, France, 69310
Contact: Christine ROUSSET-JABLONSKI, MD    04 78 56 90 49 ext +33    christine.rousset-jablonski@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Vaincre la Mucoviscidose

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03052556     History of Changes
Other Study ID Numbers: 69HCL16_0703
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
cystic Fibrosis
cervical cancer
screening
human papilloma virus (HPV)
pap smear test
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type