Human Papillomavirus and Cervical Dysplasia in Women With Cystic Fibrosis
Cystic FibrosisBackground 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.
Small Circulating RNA as Molecular Markers of Lung Disease in Cystic Fibrosis
Cystic FibrosisThe aim of our study is to assess miRNAs expression profiles in the circuling blood of patients with cystic fibrosis and highlight "signatures" that could reflect the pulmonary status of patients
Glutamine Supplementation in Cystic Fibrosis
Cystic FibrosisImmune FunctionPatients with cystic fibrosis develop frequent and potentially life-threatening lung infections. Recent studies suggest that the nutrient "glutamine" may help the body fight off infection. Glutamine is an amino acid; a type of nutrient the body requires to build muscle. It is one of the building blocks of protein. During an illness, blood levels of glutamine tend to be lower than normal. Also, many patients with cystic fibrosis have difficulty getting normal levels of nutrients from food. The aim of this study is to see if patients with cystic fibrosis have low levels of glutamine when they experience an infection, and whether a dietary glutamine supplement taken daily for three months can raise these levels. We also want to see if this supplement can improve other blood markers of immunity (the body's ability to defend itself from infection). We hope to enroll 40 people with cystic fibrosis who experience a lung infection, over a one year period, into this study.
Efficacy Study of IgY (Antibody Against Pseudomonas) in Cystic Fibrosis Patients
Cystic FibrosisThe purpose of this study is to prolong the time to reinfection with Pseudomonas aeruginosa after successfully treated acute or intermittent infection.
Study to Assess Efficacy of AZD1236 in Patients With Cystic Fibrosis
Cystic FibrosisThe purpose of this study is to determine the effect of AZD1236 in patients with cystic fibrosis (CF) on inflammatory biomarkers in induced sputum, after a treatment period of 4 weeks.
Comparison of Absorption of Vitamin D in Cystic Fibrosis
Cystic FibrosisThe investigators predict that a powder pill form of vitamin D will be more effectively absorbed than an oil form of vitamin D in people diagnosed with Cystic Fibrosis.
Zoledronic Acid in Cystic Fibrosis
Cystic FibrosisNull hypotheses: zoledronic acid does not improve bone density in cystic fibrosis. Low bone mineral density (osteoporosis) is prevalent in adults with cystic fibrosis (CF); they have an increased rate of bone fractures in comparison to the general population. CF patients start to lose bone density in adolescence/early adulthood due to an imbalance in bone breakdown and formation. Predicted survival for patients with CF has increased from 16 years in 1970 to 36.5 years in 2009 which has resulted in an increase in comorbidities associated with increased longevity in CF e.g. decreased bone density. Oral and intravenous bisphophosphonates are known to increase bone density in CF; the current licensed oral preparations require daily or weekly dosing which are difficult to maintain. Zoledronate, which is licensed for use, is administered intravenously once a year which should be easier to administer. The current evidence relates to its use in other disease groups e.g. glucocorticoid induced osteoporosis and oncology. The purpose of this study is to ascertain its efficacy in cystic fibrosis.
Growth Hormone Use in Adolescents and Adults With Cystic Fibrosis
Cystic FibrosisWe hypothesize that the anabolic effects of growth hormone (GH) will improve the clinical status of patients with CF by improving lean body mass, osteopenia, muscle strength, pulmonary function, and quality of life. We will recruit 40 malnourished CF patients for this 12-month study. All 40 patients will be treated with recombinant human growth hormone (rhGH). Each patient will serve as his/her own control by obtaining medical records for 6 months to 1 year prior to study enrollment or by completing 6 months of study without GH prior to being treated for 1 yr. with GH.
Assessing Mucociliary Clearance and Airway Liquid Volume in the CF Airway
Cystic FibrosisThe objective of this study is to determine the effect of airway surface liquid (ASL) volume on mucociliary clearance in cystic fibrosis (CF). A two-isotope nuclear medicine technique will be utilized. This pilot trial will include the imaging of n=7 CF subjects and n=7 healthy subjects. The trial will include one study visit per subject that will take approximately 3 hours. Hypothesis: The simultaneous imaging of both a "floating" and a "penetrating" radioisotope tag will allow the relative effect of airway surface liquid volume on mucociliary clearance to be determined when evaluated in CF and normal subjects.
Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes
DiabetesThis study will test the hypothesis that oral repaglinide is equivalent to insulin in the treatment of new-onset CFRD in adolescents. In addition, successful treatment of CFRD with repaglinide will improve nutritional status, ameliorate declines in pulmonary function, and will not have a negative impact upon quality of life.