Human Papillomavirus and Cervical Dysplasia in Women With Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03052556
• Date of registration: 10/02/2017
• Prospective Registration: Yes
• Primary sponsor: Hospices Civils de Lyon
• Public title: Human Papillomavirus and Cervical Dysplasia in Women With Cystic Fibrosis MUCOHPV
• Scientific title: Prevalence and Persistence of Human Papillomavirus (HPV) and of Cervical Dysplasia in a Cohort of Women With Cystic Fibrosis
• Date of first enrolment: March 8, 2017
• Target sample size: 85
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03052556
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Screening. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Procedure: Pap smear test and HPV test

Primary Outcome(s)

Prevalence of HPV carriage [Time Frame: day 0]

Secondary Outcome(s)

Rate of HPV persistence (> 12 months) [Time Frame: 12 months]

Rate of worsening of cervical dysplasia [Time Frame: 12 months and 24 months]

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]

Presence of factors associated with the prevalence of HPV [Time Frame: day 0]

mean time of HPV clearance [Time Frame: 6 months, 12months, 18months and 24months]

Rate of persistence of cervical dysplasia [Time Frame: 12 months and 24 months]

Secondary ID(s)

69HCL16_0703

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Vaincre la Mucoviscidose