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BIOCROSS - BIOmarkers in CROSS-sectional study

The BIOCROSS (BIOmarkers in CROSS-sectional) study is a collaboration between 3 Swedish universites and hospitals, and its aim is to discover and evaluate possible new biomarkers, and provide new knowledge that can contribute to new diagnostic tools and an improved and more guided treatment of asthma.

Background

A large problem when it comes to the diagnosis, follow-up and development of new treatments for asthma and other lung and respiratory diseases, is the lack of outcome variables that can predict clinical outcome. Lung function measurements can give useful information about certain aspects of the disease activity, but are not so useful when it comes to gradation and types of chronic inflammation in the airways. To identify biomarkers that reflect ongoing inflammation and airway remodelling that is ongoing in the asthmatic airways, is crucial in the understanding of different kinds of asthma and in the long run for the development of personalised treatments. Because asthma is a heterogeneous disease where symptoms, trigger factors (for instance infectious asthma, allergic asthma, non-allergic asthma, etc.) and underlying molecular mechanisms can vary, it is feasible that a combination of several different types of outcome variables and biomarkers may need to be used.

Study aim

The BIOCROSS (BIOmarkers in CROSS-sectional) study is a collaborative project in Sweden with the aim to study well-characterised patients with mild and severe asthma, healthy controls as well as comparison groups of patients with other respiratory diseases. The aim is to get closer to the clinical daily routines by means of collection of non-invasive blood, urine, saliva and exhaled breath samples, in order to do a large number of analyses of biomarkers and molecules with techniques that complement each other (transcriptomics, proteomics, lipidomics, genomics and epigenomics).

The collection of samples and molecular analyses is done according to a detailed protocol and Standard Operating Procedures and will be compiled with a broad systems biology strategy with the overarching aim to discover new biomarker profiles. This integration of information means that physiological and clinical measures can be compared with the biomarker profiles that are identified in blood, urine, saliva and exhaled breath.

Swedish collaboration

The study is a collaboration between the Karolinska Institutet, the Karolinska University Hospital, the Uppsala University Hospital, the Sahlgrenska University Hospital, the University of Gothenburg and Uppsala University, as part of the ChAMP project. The project is coordinated by Prof. Sven-Erik Dahlén at the Centre for Allergy Research and Institute of Enviromental Medicine at the Karolinska Institutet. The study is mainly financed through a grant from the Swedish Foundation for Strategic Research (SSF).

Scientific hypotheses

Through integration of physiological and clinical variables with biomarker profiles, it will be possible to identify different types of asthma which will form the grounds for improved diagnostics and follow-up of disease progress, as well as personalised treatment. Parallel studies of different patient groups with the same methodology will make it possible to specify differences and similarities between different lung diseases. This in turn will contribute to better diagnostics and understanding of disease mechanisms of COPD, bronchiectasis, sarcoidosis and interstitial lung disease.

Study design

The project is a cross-sectional collection of samples for biomarker research, as well as collection of physiological and clinical measures, in healthy controls and in clinically well characterized and phenotyped patients belonging to different disease-groups as seen in the every-day clinic. A total of up to 900 subjects (males and females aged 18 years or older) will be recruited and enrolled into the 7 cohorts over the study period. Patients will be recruited to include 200 severe asthmatics and 100 mild to moderate asthmatics, 100 COPD patients stages II-III, 100 sarcoidosis patients, 100 subjects with bronchiectasis and 100 subjects with interstitial lung diseases (both idiopathic pulmonary fibrosis and non-specific interstitial lesions). In addition, the intention is to recruit 200 healthy control subjects who are age- and gender-matched because many biomarker candidates display relations to sex and age.

All patient groups and the healthy controls will be invited to a screening visit and baseline visit for measurement of baseline data, and in some cases (20 individuals per group) also a follow-up visit after 4 months. The patient group with severe eosinophilic asthma will in addition be invited to two follow-up visits when the tests are repeated, both after 4 months and after 12 months.

Time period

The study started during the second half of 2017, and data collection is envisaged to take place during 2 years. Data and samples analyses will continue for a number of years afterwards.

Ultimate goal

There is a lack of both diagnostic tests and measuring variables for the follow-up of asthma. Asthma cannot be prevented or cured and there is no effective treatment available for patients with severe asthma. BIOCROSS aims to discover and evaluate possible new biomarkers, and provide new knowledge that can contribute to new diagnostic tools and an improved and more guided treatment of asthma.

SSF film

The Swedish Foundation for Strategic Research has created a film about the BIOCROSS project. You can see it here.

Contact

To find out more about the study, please contact:

Professor

Sven-Erik Dahlen

Telefon: 08-524 872 03
Enhet: Experimentell astma och allergiforskning
E-post: sven-erik.dahlen@ki.se