C25
Conditions
Interventions
Group 1: Patients with neoadjuvant therapy for pancreatic ductal adenocarcinoma.
Sponsors
Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie, Universitätsklinikum Carl Gustav Carus der TU Dresden
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Initial inclusion criteria - High-grade suspicion of pancreatic tumor on imaging. Specific inclusion criteria after staging/histologic confirmation: - Histologically confirmed, irresectable or borderline resectable pancreatic ductal adenocarcinoma (cT3-4 cNx M0) according to NCCN guidelines or the consensus of the International Study Group of Pancreatic Cancer. - Exclusion of distant metastases by imaging of thorax/abdomen - Planned implementation of neoadjuvant systemic therapy - No contraindication to resection of the primarius (general operability given) - No contraindications to performing neoadjuvant systemic therapy - Female and male patients = 18 years of age. - ECOG score = 2 - Patient is able and willing to give written informed consent and comply with the study protocol.
Exclusion criteria
Exclusion criteria: - Patients with recurrence (with or without previous incomplete/complete tumor resection) - Patients with previous systemic tumor-specific therapy (such as chemotherapy or targeted therapy) - Patients who are housed in a closed facility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. correlation of response of a patient-individual cell culture model with surgical R0 resectability and histological regression grade. 2. correlation of exosomes in serum with surgical R0 resectability and histological regression grade. 3. correlation of KRAS mutation frequency in serum with surgical R0 resectability and histological regression grade. More than 90% of pancreatic cancers have KRAS mutation, so this marker is suitable for therapy monitoring. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. correlation of response in CT and PET-MRI performed after neoadjuvant therapy as part of routine clinical practice with surgical R0 resectability, histological regression grade, response of the patient-specific cell culture model, and detection of exosomes and KRAS mutation frequency in serum. cell culture model, detection of exosomes, and KRAS mutation frequency in serum. 2. correlation of the above factors with disease-free and overall survival. | — |
Countries
Germany
Contacts
Public ContactDaniel Stange
Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie, Universitätsklinikum Carl Gustav Carus der TU Dresden
Outcome results
None listed