Chronic Nasal CongestionBioCyFiNCT02710383
Biomarker for Cystic Fibrosis
An observational study of Chronic Nasal Congestion and Lung Infection, run by CENTOGENE GmbH Rostock at 5 sites in 5 countries.
Trial summary
International, multicenter, observational, longitudinal study to identify biomarker/s for Cystic fibrosis and to explore the clinical robustness, specificity, and long-term variability of these biomarker/s Read more about this study
- Who is it for?
- Ages 2 months to 50 years
- Conditions the study is for
- Chronic Nasal Congestion, Lung Infection, Breathlessness
- How many people
- 54 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 20 Aug 2018to 31 Dec 2022
- 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 2 months to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants genetically diagnosed with Cystic fibrosis
Who may be able to join
- Informed consent is obtained from the participant or the parent/ legal guardian
- The participant is aged between 2 months and 50 years
- The diagnosis of Cystic fibrosis is genetically confirmed by CENTOGENE
Who cannot join
- Informed consent is not obtained from the participant or from the parent/ legal guardian
- The participant is younger than 2 months or older than 50 years
- The diagnosis of Cystic fibrosis is not genetically confirmed by CENTOGENE
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Georgia1 site
Department of Molecular and Medical Genetics, Tbilisi State Medical University
Tbilisi, 0177
India1 site
Amrita Institute of Medical Sciences & Research Centre
Kochi, Kerala, 682041
Pakistan1 site
Department of Pediatric Gastroenterology and Hepatology, The Children's Hospital and Institute of Child Health
Lahore, 54600
About this study
Official title: Biomarker for Cystic Fibrosis: An International, Multicenter, Observational, Longitudinal Protocol
International, multicenter, observational, longitudinal study to identify biomarker/s for Cystic fibrosis and to explore the clinical robustness, specificity, and long-term variability of these biomarker/s
Read the detailed description
Cystic fibrosis (CyFi) is a progressive hereditary disease with the prevalence of 1 in 2500. CyFi is an autosomal recessive disease caused by pathogenic variant/s in the CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) gene encoding Cftr protein.
CyFi causes chronic respiratory damage. Pulmonary findings occur already in infancy, which raises questions whether obstruction might be congenital. Thick, sticky mucus clogs the airways, reduces muco-ciliary clearance and leads to problems with breathing and recurrent bacterial (Pseudomonas aeruginosa) infections, which causes over time the formation of scar tissue (fibrosis) and cysts in the lungs.There is no cure for CyFi; however, symptomatic treatment can help relieve symptoms.
The aim of this study is to identify biomarkers for Cystic fibrosis disease and to explore their clinical robustness, specificity, and long-term variability. An ideal biomarker plays an essential role in the early diagnosis, prediction and therapeutic monitoring of a specific disorder.
- Conditions
- Chronic Nasal Congestion, Lung Infection, Breathlessness, Clubbing Toes, Meconium Ileus, Failure to Thrive
- Keywords
- Cystic Fibrosis, Biomarker
- Medical subject headings
- Dyspnea, Meconium Ileus, Failure to Thrive, Pancreatitis, 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 |
|---|---|---|
| Participants genetically diagnosed with Cystic fibrosis | Participants diagnosed with Cystic fibrosis aged between 2 months and 50 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Cystic fibrosis biomarker/s
All samples will be analyzed for the identification of biomarker/s via Liquid Chromatography Multiple Reaction-monitoring Mass Spectrometry (LC/MRM-MS) and compared to merged control, in order to establish the disease-specific biomarker/s. The LC/MRM-MS is performed on an ABSciex 6500 triple quadrupole mass spectrometer, coupled with a Waters Acquity UPLC
Measured: 36 months
Secondary outcomes (1)
Exploring the clinical robustness, specificity, and long-term variability of Cystic fibrosis biomarker/s
Samples will be analyzed for the identified biomarker candidates via Liquid Chromatography Multiple Reaction-monitoring Mass Spectrometry (LC/MRM-MS) and compared to merged control, in order to establish the disease-specific biomarker/s. The LC/MRM-MS is performed on an ABSciex 6500 triple quadrupole mass spectrometer, coupled with a Waters Acquity UPLC.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study start20 Aug 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: Study no longer pursued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Nasal CongestionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- CENTOGENE GmbH Rostock
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Bauer, Prof. Dr., Study chair, Centogene GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710383
- Sponsor's protocol ID
- BCF 06-2018
- Acronym
- BioCyFi
- Status last verified
- Feb 2023
- First submitted
- 11 Mar 2016
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker for Cystic Fibrosis: An International, Multicenter, Observational, Longitudinal Protocol
- ClinicalTrials.gov ID
- NCT02710383
- Acronym / sponsor ID
- BioCyFi / BCF 06-2018
- Conditions
- Chronic Nasal Congestion, Lung Infection, Breathlessness, Clubbing Toes, Meconium Ileus, Failure to Thrive
- Keywords
- Cystic Fibrosis, Biomarker
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study no longer pursued.
- Enrolment
- 54 participants (actual)
- Lead sponsor
- CENTOGENE GmbH RostockIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 16 Mar 2016 (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.
International, multicenter, observational, longitudinal study to identify biomarker/s for Cystic fibrosis and to explore the clinical robustness, specificity, and long-term variability of these biomarker/s
Detailed description
Cystic fibrosis (CyFi) is a progressive hereditary disease with the prevalence of 1 in 2500. CyFi is an autosomal recessive disease caused by pathogenic variant/s in the CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) gene encoding Cftr protein.
CyFi causes chronic respiratory damage. Pulmonary findings occur already in infancy, which raises questions whether obstruction might be congenital. Thick, sticky mucus clogs the airways, reduces muco-ciliary clearance and leads to problems with breathing and recurrent bacterial (Pseudomonas aeruginosa) infections, which causes over time the formation of scar tissue (fibrosis) and cysts in the lungs.There is no cure for CyFi; however, symptomatic treatment can help relieve symptoms.
The aim of this study is to identify biomarkers for Cystic fibrosis disease and to explore their clinical robustness, specificity, and long-term variability. An ideal biomarker plays an essential role in the early diagnosis, prediction and therapeutic monitoring of a specific disorder.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants genetically diagnosed with Cystic fibrosis | – | –Participants diagnosed with Cystic fibrosis aged between 2 months and 50 years |
Who may qualify
- Ages
- 2 months to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants genetically diagnosed with Cystic fibrosis
Key inclusion criteria (3 listed)
- Informed consent is obtained from the participant or the parent/ legal guardian
- The participant is aged between 2 months and 50 years
- The diagnosis of Cystic fibrosis is genetically confirmed by CENTOGENE
Key exclusion criteria (3 listed)
- Informed consent is not obtained from the participant or from the parent/ legal guardian
- The participant is younger than 2 months or older than 50 years
- The diagnosis of Cystic fibrosis is not genetically confirmed by CENTOGENE
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
Identification of Cystic fibrosis biomarker/s
Time frame: 36 months
All samples will be analyzed for the identification of biomarker/s via Liquid Chromatography Multiple Reaction-monitoring Mass Spectrometry (LC/MRM-MS) and compared to merged control, in order to establish the disease-specific biomarker/s. The LC/MRM-MS is performed on an ABSciex 6500 triple quadrupole mass spectrometer, coupled with a Waters Acquity UPLC
1 secondary outcome
Exploring the clinical robustness, specificity, and long-term variability of Cystic fibrosis biomarker/s
Time frame: 36 months
Results and safety
The study was stopped early (reason given: Study no longer pursued.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- CENTOGENE is a rare disease company focused on transforming clinical, genetic, and biochemical data into medical solutions for patientsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Peter Bauer, Prof. Dr. study chair
Centogene GmbH
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Nasal Congestion and Lung Infection, run by CENTOGENE GmbH Rostock at 5 sites in 5 countries.
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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Albania, Georgia, India, Pakistan, Sri Lanka. 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?
The study was stopped early (reason given: Study no longer pursued.). 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?
Identification of Cystic fibrosis biomarker/s (time frame: 36 months). 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 10 Feb 2023.