Study of Urinary Predictors of Exacerbations by Biomarkers in Cystic Fibrosis
SUPERB-CF
1 other identifier
observational
29
1 country
1
Brief Summary
Study of Urinary Predictors of Exacerbations by Biomarkers in Cystic Fibrosis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2019
CompletedFirst Submitted
Initial submission to the registry
March 3, 2020
CompletedFirst Posted
Study publicly available on registry
March 5, 2020
CompletedMarch 11, 2020
March 1, 2020
1.5 years
March 3, 2020
March 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Measurement of biomarkers in the urine of CF patients to assess their potential for predicting exacerbations
Signalling molecules/acute phase proteins e.g. Interleukin 6 (IL-6), Interleukin 8 (IL-8), N-Formyl methionine Leucyl phenylalanine (fMLP), Fibrinogen, C-reactive protein (CRP). Proteases \& proteolytic activity, e.g. Matrix metalloproteases (MMP's), Myeloperoxidase (MPO), Human neutrophil elastase (HNE), Cathepsins. Protease inhibitors, e.g. Tissue inhibitor of Metalloproteinase (TIMP), Alpha-1 anti-Trypsin (A1AT), Cystatin C, Secretory leukocyte peptidase inhibitor (SLPI). Degradation products e.g. Desmosine and Elastin Fragments, Acetyl PGP (Ac-PGP). Metabolites and other urinary markers, e.g. Creatinine, Human Serum Albumin (HSA), Retinol Binding Protein 4 (RBP4), Beta 2 Microglobulin (B2M). Other markers of interest, e.g. Siglec 8, Chitinase 3 like 1 protein, Club cell protein 16 (CC16). Note. Concentrations of all these biomarkers are expressed in microgramme/ml
4 months
Eligibility Criteria
Patients with CF
You may qualify if:
- Confirmed CF diagnosis
- Aged \>18 years of age
- Patients able and willing to give informed consent
- Requirement for at least one course of intravenous antibiotics for a pulmonary exacerbation within the previous 3 months.
You may not qualify if:
- Patients not able or not willing to give informed consent
- Patients who are currently participating in another clinical trial (excluding observational studies)
- Pneumothorax or lung surgery within the previous 3 months, eye surgery (e.g. cataract operation) in the previous 4 weeks, or any other factor that prevents safe measurement of spirometry.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mologic Ltdlead
- Heart of England NHS Foundation Trustcollaborator
Study Sites (1)
Birmingham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward F Nash, BSc
Heart of England NHS Foundation Trust
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2020
First Posted
March 5, 2020
Study Start
February 1, 2018
Primary Completion
July 31, 2019
Study Completion
July 31, 2019
Last Updated
March 11, 2020
Record last verified: 2020-03