This is a non-randomized, multicenter, non-interventional study in patients with resectable PDAC. The patients are allocated to two observation groups according preoperative presence of ctDNA (Group A) or absence of detectable ctDNA (Group B) as determined in a liquid biopsy. After successful surgery of their pancreatic tumor and completion of local histological evaluation, tissue samples will be analyzed with regard to their mutational status with. Within 14 days before start of adjuvant tumor therapy another liquid biopsy will be taken to reassess the level of ctDNA after surgery. Patients will be monitored for disease recurrence according to harmonized, institutional standards using clinical, laboratory and (cross-sectional) imaging modalities. Accordingly, patients will be assessed every three months in the first eighteen months after surgery and every six months thereafter or based on clinical need for 36 months after the date of surgery Follow up will be documented until occurrence of relapse (or death if death occurs earlier than relapse/progression) for a maximum of 36 months after the date of surgery.
Study Type
OBSERVATIONAL
Enrollment
200
17-20 ml of blood will be collected prior of surgery and within 14 days before start of adjuvant chemotherapy.
Ludwig Maximilians University Munich
Munich, Bavaria, Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Uniklinik Köln
Cologne, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Technische Universität München
Munich, Germany
Universitätsklinikum Ulm
Ulm, Germany
DFS
Comparison of disease-free survival (DFS) of patients with preoperative presence of ctDNA (Group A) and absence of ctDNA (Group B)
Time frame: Follow up will be 36 months after surgery.
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