NCT04395820Active, not recruiting
Prospective Surveillance of Lung Development During Childhood, Adolescence and Adulthood in Healthy and Patients With Cystic Fibrosis
Source: ClinicalTrials.gov · Last updated 4 Nov 2020
Brief summary (registry, in English)
Cystic fibrosis (CF) is the most common lethal inherited disease in Caucasian populations. To improve survival, it is essential to understand the development, progression and treatment of CF lung disease throughout early childhood. Therefore the overall objective is to prospectively assess the clinical utility of novel and non-invasive measuring methods, namely Multiple Breath Washout and functional lung MRI in the longitudinal clinical surveillance of patients with CF and compare the results to those of healthy controls.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 5 May 2020
- Start date
- 1 Jul 2020
- Primary completion date
- 1 Dec 2050
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Diseases
- Cystic fibrosis
- NCT number
- NCT04395820
What you commit to
- Study type: Observational
- Planned participants: 250
- From 1 Jul 2020 to the primary completion date, 1 Dec 2050
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other clinically significant concomitant disease states (e.g. renal failure, hepatic dysfunction, cardiovascular disease, etc.)
- Known or suspected non-compliance, drug or alcohol abuse
- Participation in another study with investigational drug within the 30 days preceding and during the present study
Other illness
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, etc. of the participant
- Known diseases other than related to CF
- In addition for healthy individuals:
- Current upper respiratory infection (cough, cold, fever) will lead to postponement of the visit to 4 weeks after the end of symptoms
Lab values
- Continuous glucose monitor
Other
- The presence of any one of the following exclusion criteria will lead to exclusion of the participant, for example:
- Women who are pregnant or breast feeding.
- Intention to become pregnant during the course of the study
- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
- Please note that female participants who are surgically sterilised/hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
- Metal in body, e.g. pacemaker
- Subjects which are respiratory insufficient to attend on the lung function measurements (oxygen demand)
- Subjects who are unable to perform the MRI without sedation
- Participants which were born preterm (\<36. week of pregnancy)
- Current smokers
- In addition for individuals with CF:
Who the study is looking for
- Individuals with CF:
- Diagnosis of CF
- Signed written informed consent
- ≥3 - 18 years of age, depending on the cooperation and if lung function measurements are possible
- Healthy volunteers:
- Signed written informed consent
- Informed consent of participant and if under 18 years, legal representative respectively
- Children and adults with no history of chronic lung disease or acute respiratory infection in the four weeks prior to the study visit
- ≥3 - 18 years of age, depending on the cooperation and if lung function measurements are possible
Age in the registry: 3 years to 18 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Children's Hospital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.