321 Materials and Methods Study design and study population Patients were included from the IBD center database and biobank of the University Medical Center Groningen (UMCG), Groningen, the Netherlands. In total, serum samples from 101 patients with Crohn’s disease (CD) were collected. Samples were collected in the period from February 2011 to December 2018 and were stored at -80oC until further analysis. CD diagnosis was based on clinical, endoscopic, and histological criteria. Inclusion criteria for this study were as follows: an established diagnosis of CD existing for at least one year, age ≥ 18 years, and having an updated Montreal disease classification within one year of serum sampling that remained stable during follow-up. Exclusion criteria consisted of: patients undergoing any surgery or endoscopic balloon dilatation < 6 months before sampling, patients with concurrent malignancies (except for skin cancer and hematological malignancies), other fibrotic diseases (e.g., liver fibrosis/cirrhosis, lung fibrosis), or concurrent infections. In addition, serum samples from 96 healthy controls were collected, which were obtained from BioIVT (Westbury, NY, United States). The study was approved by the Institutional Review Board (IRB) of the UMCG (IRB no. 08/338). All patients and healthy controls provided written informed consent for the use of their data and serum. The study was conducted according to the principles of the Declaration of Helsinki (2013). Data collection Detailed phenotypic data were collected for all patients, including age, sex, body-mass index (BMI), smoking status, Montreal disease classification, medication use, history of bowel surgery, disease activity, and standard laboratory parameters, all of which were assessed at the time of serum sampling. Clinical disease activity was established using the Harvey-Bradshaw Index (HBI).25 The Montreal disease classification was recorded from the closest visit to the outpatient clinic at the time of sampling. In addition to clinical data, routine diagnostic laboratory parameters were collected that were measured as part of routine clinical care, including hemoglobin (Hb), C-reactive protein (CRP), white blood cell count (WBC), platelet counts, creatinine, and the estimated glomerular filtration rate (eGFR). Fecal calprotectin (FC) levels were collected from a subset of included patients for which these were available (≤ 90 days of sampling, n=38) as part of routine clinical care, which were quantified by enzyme-linked immunosorbent assays (ELISA) (Bühlmann Laboratories AG, Switzerland). Study outcomes and definitions Classification of disease behavior Disease behavior according to the Montreal classification was considered the primary study outcome and was classified as follows: B1: non-stricturing, non-penetrating disease, representing inflammatory CDwithout any prior stricturing or penetrating disease complications; B2: stricturing disease, representing the presence of stenosis, either asymptomatic or symptomatic, and either previous or current, as well as previous surgery because of stenosis, or postoperative stenosis in anastomosis; B3: penetrating disease, representing the history or current presence of fistulising Collagen biomarkers and Crohn’s disease behavior
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