An observational study in Cystic Fibrosis, sponsored by Universitätsklinikum Köln. Active, not recruiting at 8 sites in Germany. Per ClinicalTrials.gov, last updated 2024-02-26.
Sponsored by Universitätsklinikum Köln · Observational
Among 147 studies in Cystic Fibrosis with a site in Germany — 9 open to participants now, 14 under way, 5 of them phase 3. Cystic Fibrosis · Germany.
Among the 147 studies in Cystic Fibrosis with a site in Germany, this one is the 4th largest by planned enrollment of the 21 observational ones that give a count, is one of 7 that started in 2021, is one of 21 observational ones, reaches primary completion later than 0 of the 13 other live ones, and was the 126th registered.
1,619 studies on the registry are indexed under Cystic Fibrosis; 199 are open to participants now.
Browse Cystic Fibrosis studies →9 of the 147 studies in Cystic Fibrosis with a site in Germany are open now. Recruiting first, the newest first:
European Breast Cancer Research Association of Surgical Trialists · Sites in Germany
Research Center Borstel · Sites in Germany
SpliSense Ltd. · Sites in Germany, United States, Czechia and 6 more countries
University of Erlangen-Nürnberg Medical School · Sites in Germany
University Hospital of Cologne · Sites in Germany
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 154 Cystic Fibrosis studies recruiting now, 95 (62%) set no upper age limit and 43 (28%) stop at 75 or younger; 84 take children under 18; 41 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
147 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 14 · Phase 2 47 · Phase 3 62 · Phase 4 5
First in 2000; this study’s year is marked. 7 started in 2021.
This study's planned enrollment of 500 is above the median of 85 across 503 observational studies indexed under Cystic Fibrosis.
Median enrollment 103 across the 126 interventional studies, 104 across the 21 observational. Of the 125 that completed or were terminated, 78 (62%) have results posted.
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103 of 147 have an industry lead sponsor. The 10 most frequent:
Universitätsklinikum Köln is the lead sponsor of 33 studies on the registry; 5 are open to participants now.
Universitätsklinikum Köln has 1 study filed under Cystic Fibrosis — fewer than ten, so there is no comparison to draw.
6 of the studies in Cystic Fibrosis with a site in Germany that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05331183Phase 3Vertex Pharmaceuticals IncorporatedStudy to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del | 2027-04-06 |
| NCT06460506Phase 3Vertex Pharmaceuticals IncorporatedEvaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older | 2027-09-30 |
| NCT03052283Medizinische Hochschule Brandenburg Theodor FontaneDevelopment and Validation of a Disease Specific PROM to Assess Abdominal Involvement in Patients With CF (CFAbd-Score) | 2026-12-31 |
| NCT04732910Charite University, Berlin, GermanyModulate-CF: Cystic Fibrosis Transmembrane Regulator (CFTR) Biomarker Study to Evaluate the Rescue of Mutant CFTR in Patients With Cystic Fibrosis Treated With CFTR-modulators | 2027-03-31 |
| NCT04700358University Hospital of CologneCharacterization of Antibacterial Antibodies in Patients With Cystic Fibrosis | 2027-09-30 |
Among the 147 studies in Cystic Fibrosis with a site in Germany, from their registry updates:
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Coronavirus disease 2019 (COVID-19) which is caused by the virus Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) has resulted in an ongoing global pandemic. It is unclear whether the relatively low number of reported cases of COVID-19 in people with CF (pwCF) is due to enhanced infection prevention practices or whether pwCF have protective genetic/immune factors. This study aims to prospectively assess the proportion of pwCF, including both adults and children with CF who have evidence of SARS-CoV-2 antibodies over a two-year period. This study will also examine whether pwCF who have antibodies for SARS-CoV-2 have a different clinical presentation and what impact this has on their CF disease. The proposed study will recruit pwCF from paediatric and adult CF centres throughout the United Kingdom. Serological testing to detect antibodies will be performed on blood samples taken at month 0, 6, 12, 18 and 24 with additional time-points if bloodwork is available via normal clinical care. Clinical data on, lung function, CF-related medical history, pulmonary exacerbations, antibiotic use, and microbiology and vaccination receipt, will be collected during routine clinical assessments.
Associations will be examined between socio-demographic and clinical variables and serologic testing. The investigators will also examine the effects of SARS-CoV-2 infection on clinical outcomes and analyse end-points to explore any age-related or gender-based differences, as well as subgroup analysis of outcomes in lung-transplant recipients and pwCF receiving cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies. As pwCF receive COVID-19 vaccination the investigators will perform a comparison of the development and progression of anti-SARS-CoV-2 antibodies in pwCF following natural infection and vaccination SARS-CoV-2 over time.
This is a prospective, longitudinal cohort study in people with Cystic Fibrosis (pwCF) that involves repeated serial sampling of participants. This study design was chosen to provide comprehensive information on SARS-CoV-2 seroprevalence changes over time and the subsequent clinical impact on pwCF. The study will be conducted at participating CF centres over a 3-year period. Study participants will include paediatric and adult pwCF. For the United Kingdom (UK) section of the study, UK investigators in the European Cystic Fibrosis Society-Clinical Trials Network (ECFS-CTN) will be invited to participate. Participating investigators can enrol all eligible pwCF over a 12-month period. Participants are then followed up for 24 months. Participants will donate blood samples at their routine clinic visits. Blood samples will be collected at Day 0 (baseline), at Months 6, 12, 18 and 24 (to coincide with routine clinical reviews). Additional blood samples will be taken opportunistically every time the participant visits the clinic for blood draws. These blood samples could be related to, routine care, annual review visits, pulmonary exacerbations (PEx), CF complications or when initiating new treatments (e.g. CFTR modulators).
Serum from blood samples will be shipped to a central laboratory (Queen's University Belfast) for standardized measurement of SARS-CoV-2 antibodies.
Alongside the blood samples the investigator will also collect clinical data from the patient's health records and will input this data into the case report form (CRF). Clinical data will be collected in conjunction with routine care visits, according to local clinical practice. Investigators will collect data elements from information routinely recorded in the patients' medical records. Data will be collected at baseline, month 6, 12, 18 and 24 as per the study schedule, and at additional blood sampling timepoints as previously explained above. Data collection will include routine data available from CF clinic follow-ups including background demographic information, CF medical history, medications, exacerbation information, sputum microbiology and clinical and lung function parameters. Information on SARS-CoV-2 infection history and vaccine receipt will also be collected.
The maximum follow-up duration of participation in the study for each patient will be 24 months. This study duration (24-month follow-up) is justified as it provides sufficient time to observe changes in antibody prevalence over the course of the COVID-19 pandemic as well as sufficient time to determine long term clinical outcomes for pwCF who are SARS-CoV-2 seropositive. Furthermore, the investigators anticipate the 2-year study follow-up period will provide sufficient time to observe the impact of vaccination on antibody levels given that a number of vaccines are now commercially available.
The investigators will compare the level of antibody responses between natural COVID-19 infection and vaccination in pwCF and how this varies over time. This will be achieved by analyzing seroprevalence and antibody levels according to natural infection and vaccination status and according to time of sample post infection or post vaccination, if known.
Optional Study sample collection:
For participants who consent, a second blood sample will also be drawn into Ethylenediamine tetraacetic acid (EDTA) tubes (plasma). Consent to this optional study sample would allow this sample and any remaining serum (following antibody testing) to be stored for future analysis and allow further research to be carried out on related studies to COVID-19 and CF.
Participants already enrolled in a clinical trial are eligible for enrolment in this study. Inclusion in CAR-CF should not preclude enrolment in other observational clinical trial studies or clinical trials of an investigational medicinal product (CTIMP).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Consenting people with cystic fibrosis of any age, genotype, transplant status and disease severity will be eligible to participate in the study. The study population is expected to be representative of the general CF population.
Exclusion Criteria:
There are no specific exclusion criteria other than refusal to give , or to venepuncture.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
To evaluate SARS-CoV-2 seroprevalence
To evaluate SARS-CoV-2 seroprevalence in a cohort of people with cystic fibrosis, followed longitudinally over a 3-year period (comprising a 1-year enrollment period and a 2-year follow-up). \[ Time Frame: 3-year period (comprising a 1-year enrollment period and a 2-year follow-up) \] To examine the associations between SARS-CoV-2 seropositivity, clinical symptoms and clinical outcomes in a cohort of people with cystic fibrosis
Time frame: 3-year period (comprising a 1-year enrollment period and a 2-year follow-up)
Storage of samples for future analysis
Storage of samples for future analysis on the impact of COVID-19 immune response in people with cystic fibrosis
Time frame: anticipated 5-10 years
Plan to share: No
No publications or documents are linked to this record.
Started May 2021 (actual). Primary completion is estimated for May 2024, 36 months after the start.
Of 228 non-industry observational studies under Cystic Fibrosis, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 89. This study's planned 36 months is close to that.
Counting every sponsor, half of 243 studies reached it within 41 months; a quarter within 19 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Universitätsklinikum Köln