Human Papillomavirus and Cervical Dysplasia in Women With Cystic Fibrosis

NACompletedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

March 8, 2017

Primary Completion Date

September 18, 2019

Study Completion Date

September 18, 2019

Conditions
Cystic Fibrosis
Interventions
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"

Trial Locations (1)

69310

Service de Gynécologie oncologique - Centre Hospitalier Lyon Sud, Pierre-Bénite

All Listed Sponsors
collaborator

Vaincre la Mucoviscidose

OTHER

lead

Hospices Civils de Lyon

OTHER

NCT03052556 - Human Papillomavirus and Cervical Dysplasia in Women With Cystic Fibrosis | Biotech Hunter | Biotech Hunter