SP4 - SASKit

Clinical study of senescence-related and other biomarkers in pancreatic cancer patients compared to age- and sex-matched controls

Pancreatic cancer (pancreatic ductal adenocarcinoma, PDAC) is characterized by late clinical presentation, early metastases and poor prognosis, with a 1-year survival rate of only 15%. Recent developments in oncology have not shown much benefit in clinical trials of PDAC patients. Even in localized stages, PDAC appears as systemic disease: After successful resection of rare localized PDAC, many patients will show metastases within the first year.
As in cancer in general, in PDAC in particular there is an association to hypercoagulability: up to 34% of patients with metastatic PDAC develop thromboembolic complications. Whereas venous thromboembolism is the most common event and has been described for more than 100 years, more recently the association to arterial ischemic events, like stroke, has also been recognized. Still, the pathophysiology of this comorbidity is poorly understood.
We conduct a prospective, observational cohort study in patients with PDAC specifically in order to elucidate joint pathophysiology, and we maximized design overlap with subproject 5 (recruiting patients with stroke): Inclusion of 50 patients with PDAC was planned, with regular follow-up at 3 months, 6 months, 12 months, 24 months. . Demographic and clinical data are collected, clinical tests, self-administered questionnaires are performed. Blood sampling is done for differential blood count, bilirubin, albumin, cholesterol, HbA1c, CRP, CA19-9 and coagulation assays. Experimental blood analysis consists of transcriptomics and protein analysis in T cells and protein analysis in serum. Clinical important parameters are defined as endpoints: sarcopenia, deterioration of the performance status (ECOG) and quality of life. Comorbidity (i.e. vascular events) is one of the secondary endpoints. Patients living in the same household (e.g. spouses) and age- and sex-matched volunteers serve as control groups and are evaluated in the same way.
Together with subproject 5 omics data for three groups (PDAC patients, stroke patients, and controls) will be available. Experimental blood analysis is done at the same research laboratory for all participants following standardized procedures. Data analysis for the two clinical subprojects (4 und 5) together is foreseen in Summer/Fall 2023, as specified in the published study protocol (Henze et al, 2020).  We also assist the computational groups with biomarker assessment and interpretation.
The study has been approved by the ethics committee of the University Rostock Medical Center.