Cystic FibrosisNCT02603666
Elastography of the Liver in Cystic Fibrosis Patients. Diagnostic and Prognostic Aspects
A study testing Fibroscan in people with Cystic Fibrosis and Liver Fibrosis, run by Karolinska University Hospital.
Trial summary
The aim of the study is to find CF patients at risk for cystic fibrosis related liver disease (CFLD). Comparison of ultrasound by two modalities and biochemical markers with histological evaluation of liver biopsy if present. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Cystic Fibrosis, Liver Fibrosis
- What is being tested?
- Fibroscan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Verified cystic fibrosis
Who cannot join
None listed.
About this study
The aim of the study is to find CF patients at risk for cystic fibrosis related liver disease (CFLD). Comparison of ultrasound by two modalities and biochemical markers with histological evaluation of liver biopsy if present.
Read the detailed description
There are 209 CF patients attending Stockholm Cystic Fibrosis Center (January 2010). All up till 15 years of age are screened for liver disease annually by ultrasound (US) and also by biochemical markers. Ultrasound is performed every third year over 15 years of age in patients without CFLD, while all of them with diagnosed CFLD are continued to be investigated annually. Biochemical markers are controlled at least once every year in all CF patients. Elastography of the liver will be planned together with the investigations of the annual follow up, in an optimal clinical status. If either US or elastography of the liver indicates liver disease or progress of the already existing pathological changes, a liver biopsy will be performed according to routine procedure at Stockholm CF Centre. Also, historical data of liver biopsies and biochemical investigations will be considered in the study.
Elastography of the liver will be performed by Fibroscan device, with transducers for children and adults, respectively.
Clinical importance Liver US investigations in CF patients have important implications but are difficult to standardize in a routine clinical setting. Elastography may have an advantage in the evaluation of early fibrosis with clinical importance in pursuing diagnostics and intensifying treatment. A significant group (up to 25 %) of CF patients may be helped by this novel method. Including histological data, accuracy of elastography in CF patients may be improved. Further details of the importance of fatty acid status in CF may be elucidated.
- Conditions
- Cystic Fibrosis, Liver Fibrosis
- Being tested
- Fibroscan
- Keywords
- cystic fibrosis, elastography, liver biopsy
- Medical subject headings
- Cystic Fibrosis, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroscanDevice
Also called Elastography
Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| Elastography | Other | Fibroscan elastography device for evaluation of liver disease in CF patients. Receives: Device: Fibroscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elastographic Value in kPa Measured by Fibroscan
Elastographic values given in kPa by Fibroscan. All patients undergo elastographic measurement of the liver and ultrasound of the liver. The grade of fibrosis is to be established by setting the cut-off for cystic fibrosis patients.
Measured: Within 28 days in connection with their annual evaluation at a single point of time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startJan 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Ferenc Karpati, Karolinska University Hospital
- Investigators
- Ferenc Karpati, MD, PhD, Principal investigator, Stockholm CF Center, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603666
- Sponsor's protocol ID
- 2010/1957/31/3
- Status last verified
- Nov 2016
- First submitted
- 4 May 2015
- Last updated
- 30 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elastography of the Liver in Cystic Fibrosis Patients. Diagnostic and Prognostic Aspects
- ClinicalTrials.gov ID
- NCT02603666
- Acronym / sponsor ID
- 2010/1957/31/3
- Conditions
- Cystic Fibrosis, Liver Fibrosis
- Keywords
- cystic fibrosis, elastography, liver biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Jan 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Posted 30 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to find CF patients at risk for cystic fibrosis related liver disease (CFLD). Comparison of ultrasound by two modalities and biochemical markers with histological evaluation of liver biopsy if present.
Detailed description
There are 209 CF patients attending Stockholm Cystic Fibrosis Center (January 2010). All up till 15 years of age are screened for liver disease annually by ultrasound (US) and also by biochemical markers. Ultrasound is performed every third year over 15 years of age in patients without CFLD, while all of them with diagnosed CFLD are continued to be investigated annually. Biochemical markers are controlled at least once every year in all CF patients. Elastography of the liver will be planned together with the investigations of the annual follow up, in an optimal clinical status. If either US or elastography of the liver indicates liver disease or progress of the already existing pathological changes, a liver biopsy will be performed according to routine procedure at Stockholm CF Centre. Also, historical data of liver biopsies and biochemical investigations will be considered in the study.
Elastography of the liver will be performed by Fibroscan device, with transducers for children and adults, respectively.
Clinical importance Liver US investigations in CF patients have important implications but are difficult to standardize in a routine clinical setting. Elastography may have an advantage in the evaluation of early fibrosis with clinical importance in pursuing diagnostics and intensifying treatment. A significant group (up to 25 %) of CF patients may be helped by this novel method. Including histological data, accuracy of elastography in CF patients may be improved. Further details of the importance of fatty acid status in CF may be elucidated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elastography | Other | Device: FibroscanFibroscan elastography device for evaluation of liver disease in CF patients. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Verified cystic fibrosis
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| FibroscanAlso: ElastographyUltrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions. | Device | Elastography |
Primary outcome
Elastographic Value in kPa Measured by Fibroscan
Time frame: Within 28 days in connection with their annual evaluation at a single point of time
Elastographic values given in kPa by Fibroscan. All patients undergo elastographic measurement of the liver and ultrasound of the liver. The grade of fibrosis is to be established by setting the cut-off for cystic fibrosis patients.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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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.
Ferenc Karpati, MD, PhD principal investigator
Stockholm CF Center, Karolinska University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Fibroscan in people with Cystic Fibrosis and Liver Fibrosis, run by Karolinska University Hospital.
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 1 inclusion and 0 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 30 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 30 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Elastographic Value in kPa Measured by Fibroscan (time frame: Within 28 days in connection with their annual evaluation at a single point of time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2016.