C25
Conditions
Interventions
Group 1: Within the planned trial, we will measure ctDNA in patients with early stage pancreatic cancer undergoing curatively intended surgery. The major goals of this study will be to determine wheth
Sponsors
Universitätsklinikum Freiburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key inclusion criteria are resectable pancreatic adenocarcinoma and curatively intended, macroscopically complete (R0/R1) resection.
Exclusion criteria
Exclusion criteria: Key exclusion criteria are Stage IV metastatic disease diagnosed prior to or during surgery and Non-resectable tumour or macroscopically incomplete (R2) resection. Histology other than primary adenocarcinoma is also not included. Other key exclusion criteria are malignancies diagnosed within the previous five years of diagnosis (except non-melanoma skin cancer and carcinoma in situ of the cervix uteri).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence (yes/no) of the marker: Presence of detectable mutated tumor-derived cell-free DNA (ctDNA) in at least one of six plasma samples | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are the Relapse-free survival, to be studied for association with preceding dynamic changes in the occurrence and concentration levels of ctDNA. Besides that we want to analyze changes in ctDNA concentration over time. Furthermore we analyze clinical characteristics of ctDNA-positive and ctDNA-negative patients (TNM stage conventional tumour markers, clinical presentation, histologic subtype and grading). | — |
Countries
Germany
Contacts
Public ContactRalph Fritsch
Zentrum für Gastrointestinale Tumoren (ZGT)Klinik für Innere Medizin I Schwerpunkt Hämatologie, Onkologie und StammzelltransplantationUniversitätsklinikum Freiburg
Outcome results
None listed