Cystic FibrosisMUCOHPVNCT03052556
Human Papillomavirus and Cervical Dysplasia in Women With Cystic Fibrosis
A study testing Pap smear test and HPV test in people with Cystic Fibrosis, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Pap smear test and HPV test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- 8 Mar 2017to 18 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age under 18
- Refusal to participate in the study
- Patient under tutorship / curatorship
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Gynécologie oncologique - Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69310
About this study
Official title: Prevalence and Persistence of Human Papillomavirus (HPV) and of Cervical Dysplasia in a Cohort of 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.
Read more
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
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
- Being tested
- Pap smear test and HPV test
- Keywords
- cystic Fibrosis, cervical cancer, screening, human papilloma virus (HPV), pap smear test
- Medical subject headings
- Cystic Fibrosis, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pap smear test and HPV testProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Pap smear test and HPV test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of HPV carriage
Genomic DNA microarray assay enabling the detection of 35 different HPV genotypes will be performed.
Measured: day 0
Secondary outcomes (7)
Rate of HPV persistence (> 12 months)
In case of a HPV positive test at inclusion, HPV tests will be repeated every 6 months during the study.
Measured: 12 months
mean time of HPV clearance
In case of a HPV positive test at inclusion, HPV tests will be repeated every 6 months during the study.
Measured: 6 months, 12months, 18months and 24months
Presence of factors associated with the prevalence of HPV
factors studied are : transplantation, smoking, age at first intercourse, number of sexual partners in the year, contraception, gravidity and parity, HPV vaccination
Measured: day 0
Prevalence of cervical dysplasia or vulvar/vaginal/cervical condylomatosis
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.
Measured: day 0
Rate of spontaneous regression of cervical dysplasia
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
Measured: 12 months and 24 months
Rate of persistence of cervical dysplasia
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
Measured: 12 months and 24 months
Rate of worsening of cervical dysplasia
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
Measured: 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start8 Mar 2017
- Primary completion18 Sep 2019
- Study completion18 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Vaincre la Mucoviscidose
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052556
- Sponsor's protocol ID
- 69HCL16_0703
- Acronym
- MUCOHPV
- Status last verified
- Sep 2025
- First submitted
- 10 Feb 2017
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36526553
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Persistence of Human Papillomavirus (HPV) and of Cervical Dysplasia in a Cohort of Women With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03052556
- Acronym / sponsor ID
- MUCOHPV / 69HCL16_0703
- Conditions
- Cystic Fibrosis
- Keywords
- cystic Fibrosis, cervical cancer, screening, human papilloma virus (HPV), pap smear test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Vaincre la Mucoviscidose
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 18 Sep 2019 (actual)
- Study completion
- 18 Sep 2019 (actual)
- First posted
- 14 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort of women with cystic fibrosis | Other | Procedure: Pap smear test and HPV testIncludable patients are adult women, transplanted or not, followed at Lyon CRCM (Centre de Ressources et de Compétences de la Mucoviscidose). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Age under 18
- Refusal to participate in the study
- Patient under tutorship / curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pap smear test and HPV testIncluded 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 | Procedure or surgery | Cohort of women with cystic fibrosis |
Primary outcome
Prevalence of HPV carriage
Time frame: day 0
Genomic DNA microarray assay enabling the detection of 35 different HPV genotypes will be performed.
7 secondary outcomes
Rate of HPV persistence (> 12 months)
Time frame: 12 months
mean time of HPV clearance
Time frame: 6 months, 12months, 18months and 24months
Presence of factors associated with the prevalence of HPV
Time frame: day 0
Prevalence of cervical dysplasia or vulvar/vaginal/cervical condylomatosis
Time frame: day 0
Rate of spontaneous regression of cervical dysplasia
Time frame: 12 months and 24 months
Rate of persistence of cervical dysplasia
Time frame: 12 months and 24 months
Rate of worsening of cervical dysplasia
Time frame: 12 months and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Results publication: PubMed 36526553Rousset-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pap smear test and HPV test in people with Cystic Fibrosis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of HPV carriage (time frame: day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03052556, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.