BBMRI.at partner – JKU Biobank Linz – involved in international multi-centre COPD cohort study “CATALINA”

Figure: Study Progress Tracker as of August 1^st, 2025 (CICERO Website)

The CATALINA study objectives are:

1. To generate high-quality longitudinal clinical data (incl. biological samples) covering a pan-European real-life population of patients with COPD, hospitalized for an exacerbation, in all age groups and stages of disease severity
2. To establish standard operating procedures for sample collection, processing and local bio-banking
3. To determine phenotypes of exacerbations, identify biomarkers and treatable traits; and explore how these relate to known exacerbation phenotypes
4. To better understand the natural history and prognosis of COPD in patients experiencing severe exacerbations, with the aim of creating and validating prognostic tools to support medical decision making
5. To cultivate the development of a phenotyped COPD patient database in relation to the type of exacerbation for future trial cohorts
6. To serve as an exploratory dataset to design future interventions studies for specific patient subgroups

Logistics of human sample and associated data

Patient samples including sputum, blood, urine and nasal swabs are (to be) collected and processed at fixed time-points. All clinical data and biological samples obtained during participation in the study are pseudonymised before being stored in an electronic database or in the local biobank. For a period of up to 4 years, samples and data are stored at the local study centres of the multi-centre study, i.e. in the case of the study centre Kepler university hospital at the JKU biobank Linz. Upon completion of the study, the pseudonymised biological samples will be transferred from the local JKU biobank Linz to a central biobank to be selected by the sponsor (either in Leuven, Belgium, or in London or Oxford in the United Kingdom).

JKU biobank Linz staff execute adequate source documentation for all collected biosamples and their associated data. The local investigator and designated personnel ensure correct and complete input of all study data (including biobanking data) into the eCRF (electronic case report form), which will be monitored remotely by the CICERO data manager.

Transfer of the samples will be subject to a material transfer agreement. Any study participant records or datasets that are transferred to the sponsor or any partners of the sponsor will contain the study-specific participant identifier only; participant names or any information which would make the participant identifiable will not be transferred.

Sample Schedule

Participation in this clinical trial is expected to last 12 months per patient. Biobank sample processing is coupled to the study visit schedule shown below. Some visits (e.g. visit 1) require processing of multiple sample types (sputum + blood fractions + nasal swabs + urine), others require processing of less sample types (e.g. blood only).

• 3 study visits will be scheduled during the hospitalization period of the index acute exacerbation:
  • visit 1: within 48 h of hospital admission, study inclusion (Day 1)
  • visit 2: at 72 h after study inclusion (Day 3)
  • visit 3: at day of hospital discharge (only if ≥ 6 days in hospital)

• 3 study visits will be scheduled during the outpatient setting:
  • visit 4: at 3 months after study inclusion (Day 90)
  • visit 5: at 6 months after study inclusion (Day 180)
  • visit 6: at 12 months after study inclusion (Day 365)

• The first hospital readmission for respiratory reasons during the patient’s study participation will undergo the same testing schedule as mandated during the hospitalization period of the index event:
  • unscheduled visit 1: within 48 h of first hospital readmission
  • unscheduled visit 2: within 72 h of first hospital readmission
  • unscheduled visit 3: at day of hospital discharge (only if ≥ 6 days in hospital)

Pre-analytical workflow of biobank samples

Sample processing is done according to a harmonized study protocol, applicable to all participating study centres.

At JKU Biobank Linz all involved persons are well trained with respect to the correct pre-analytical workflow for the processing of the various sample types with all the different sample types arriving nearly at the same  time. A tight coordination between clinical study team and biobank team has been implemented. Among the spectrum of processed sample material types (sputum, blood, urine, nasal swabs), sputum samples show heterogenous consistencies (e.g. number of sputum plugs, viscosity). The complexity of this sample type and accordingly number of processing steps has to be considered in the consumed hand-on time.

The core sample processing workflow is supported by a standardized and fast sample transport line to the biobank laboratory. Processed samples are quickly frozen using an appropriate freezing platform in the processing lab. Collected samples of each processing session will further be transferred to ‑80°C freezers for long-term storage. Where needed (e.g. sputum cells), long-term storage is done in cryotanks in the liquid nitrogen vapor phase.