Cystic FibrosisNCT01446861
Exocrine Pancreatic Function Testing in Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
Purpose The purpose of this study is to develop and validate multimodal testing of exocrine pancreatic function (EPF). The investigators will be testing exocrine pancreatic function in patients with cystic fibrosis (CF). Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2011to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Cystic fibrosis patients over the age of 15 years Healthy controls between 18 and 67 years
Who may be able to join
- Diagnosis cystic fibrosis. Age over 15 years. Assigned to routine control at department of lung diseases, Haukeland university hospital.
Who cannot join
- Unable to concent, allergies to Sonovue ultrasound contrast, pregnant or breastfeeding, contraindications against endoscopy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pancreatic Failure in Patients With Cystic Fibrosis A Multimodal Study of Exocrine Pancreatic Failure in Cystic Fibrosis
Purpose The purpose of this study is to develop and validate multimodal testing of exocrine pancreatic function (EPF). The investigators will be testing exocrine pancreatic function in patients with cystic fibrosis (CF). Exocrine pancreatic function and imaging will be correlated to age group, genotype, nutritional status and quality of life. Earlier detection of exocrine pancreatic failure in the non classical form of cystic fibrosis may be of therapeutically benefit.
Hypotheses Endoscopic short test can be applied in diagnosing and monitoring exocrine pancreatic function in patients with cystic fibrosis.
Read more
New functional testing of exocrine pancreatic function is superior to traditional testing with fecal elastase.
MRI and ultrasound methods can give volume output estimate in cystic fibrosis patients.
Contrast enhanced ultrasound can quantify reduced or delayed pancreatic perfusion and parenchymal changes in cystic fibrosis patients.
Elastography/ CEUS can be used in prediction and monitoring of fibrosis development and development of hepatocellular carcinoma in the liver of cystic fibrosis patients.
Immunohistochemical quantification of secretin/ cholecystokinin (CCK) producing cell in duodenum can be utilized as a model hormonal signaling in cystic fibrosis patients with exocrine pancreatic function.
Read the detailed description
Study design: Observational, cohort studies.
Patient characterization: Age, gender, and Genetic status from electronical records.
Exocrine function testing (EPF): Secretin stimulated ultrasound and short endoscopic secretin test (EST). Faecal Elastase.
Imaging: Transabdominal ultrasound of the liver and pancreas. secretin stimulated MRI. Contrast enhanced ultrasound (CEUS) of the pancreas using SonoVue contrast.
Endpoints:
Study 1: Exocrine pancreatic function by duodenal bicarbonate/ Enzymes related to Genetics and F elastase.
Study 2: Ultrasound parenchymal changes of the pancreas related to Genetics and EPF.
Study 3/4: Pancreatic secretion by ultrasound, MRI and EST related to EPF Study 5; Perfusion of the pancreas by CEUS related to EPF
Study 6: Genotype-phenotype conciderations of the CF pancreas.
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, Pancreas, Exocrine function, Ultrasound, Contrast ultrasound
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cystic fibrosis patients | Consecutive cystic fibrosis patients attending regular Controls at the CF clinic in Bergen | |
| Healthy controls | Age and gender matchet healthy Controls recruited by Board notice and advertising. |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak lipase IE
Measured: one year
Secondary outcomes (1)
enzyme production
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Sponsor
- Investigators
- Georg Dimcevski, MD, PhD, Principal investigator, Haukeland University HospitalOdd H Gilja, Professor, Study director, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446861
- Sponsor's protocol ID
- 2010/2857-7
- Status last verified
- Aug 2016
- First submitted
- 4 Oct 2011
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be published in peer rewieved journals
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Failure in Patients With Cystic Fibrosis A Multimodal Study of Exocrine Pancreatic Failure in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01446861
- Acronym / sponsor ID
- 2010/2857-7
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, Pancreas, Exocrine function, Ultrasound, Contrast ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- Jan 2011
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 5 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose The purpose of this study is to develop and validate multimodal testing of exocrine pancreatic function (EPF). The investigators will be testing exocrine pancreatic function in patients with cystic fibrosis (CF). Exocrine pancreatic function and imaging will be correlated to age group, genotype, nutritional status and quality of life. Earlier detection of exocrine pancreatic failure in the non classical form of cystic fibrosis may be of therapeutically benefit.
Hypotheses Endoscopic short test can be applied in diagnosing and monitoring exocrine pancreatic function in patients with cystic fibrosis.
New functional testing of exocrine pancreatic function is superior to traditional testing with fecal elastase.
MRI and ultrasound methods can give volume output estimate in cystic fibrosis patients.
Contrast enhanced ultrasound can quantify reduced or delayed pancreatic perfusion and parenchymal changes in cystic fibrosis patients.
Elastography/ CEUS can be used in prediction and monitoring of fibrosis development and development of hepatocellular carcinoma in the liver of cystic fibrosis patients.
Immunohistochemical quantification of secretin/ cholecystokinin (CCK) producing cell in duodenum can be utilized as a model hormonal signaling in cystic fibrosis patients with exocrine pancreatic function.
Detailed description
Study design: Observational, cohort studies.
Patient characterization: Age, gender, and Genetic status from electronical records.
Exocrine function testing (EPF): Secretin stimulated ultrasound and short endoscopic secretin test (EST). Faecal Elastase.
Imaging: Transabdominal ultrasound of the liver and pancreas. secretin stimulated MRI. Contrast enhanced ultrasound (CEUS) of the pancreas using SonoVue contrast.
Endpoints:
Study 1: Exocrine pancreatic function by duodenal bicarbonate/ Enzymes related to Genetics and F elastase.
Study 2: Ultrasound parenchymal changes of the pancreas related to Genetics and EPF.
Study 3/4: Pancreatic secretion by ultrasound, MRI and EST related to EPF Study 5; Perfusion of the pancreas by CEUS related to EPF
Study 6: Genotype-phenotype conciderations of the CF pancreas.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystic fibrosis patients | – | –Consecutive cystic fibrosis patients attending regular Controls at the CF clinic in Bergen |
| Healthy controls | – | –Age and gender matchet healthy Controls recruited by Board notice and advertising. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cystic fibrosis patients over the age of 15 years Healthy controls between 18 and 67 years
Key inclusion criteria (1 listed)
- Diagnosis cystic fibrosis. Age over 15 years. Assigned to routine control at department of lung diseases, Haukeland university hospital.
Key exclusion criteria (1 listed)
- Unable to concent, allergies to Sonovue ultrasound contrast, pregnant or breastfeeding, contraindications against endoscopy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
peak lipase IE
Time frame: one year
1 secondary outcome
enzyme production
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
- Individual participant dataSharing planned: Yes. Data will be published in peer rewieved journals
Related trials for Cystic Fibrosis
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Diagnostic Value of Oropharyngeal Suction and Effect of Respiratory Physiotherapy on the Detection of Microorganisms in the Pediatric Patient
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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.
Georg Dimcevski, MD, PhD principal investigator
Haukeland University Hospital
Odd H Gilja, Professor study director
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Haukeland University Hospital at 1 site in Norway.
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 1 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: status not confirmed, as of the sponsor's last update on 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
peak lipase IE (time frame: one year). 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 24 Aug 2016.