Associations of intestinal microbiota signatures with the efficacy and toxicity of chemotherapy in patients with advanced pancreatic cancer

ABSTRACT: Interventions: Group 1: A cohort of patients with locally advanced or metastatic PDAC or recurrence after PDAC resection who will receive palliative chemotherapy following medical indication will be recruited at the NCT Heidelberg by medical professionals; additional recruitment-centers are the Tumor Center of the University Hospital Cologne, the West German Tumor Center in Essen and the Clinical Center Darmstadt. Patients will be informed about the possibility of participating in this study before using the material obtained during routine surgery or medical care. The oral and fecal samples will be collected at several points: at the time of diagnosis or initiation of chemotherapy and longitudinally at regular timepoints within 12 months after the start of chemotherapy (i.e., approximately every 4 weeks). Stool samples and oral samples are collected from patients at the time of their routine clinic visits or at home. The indication and choice of chemotherapy is based purely on medical reasons and is independent of this study. In addition to the biomaterial, clinical data collected during clinical routine, such as medication (including chemotherapy regimen, antibiotics, etc.), blood values (serum chemistry, blood count), therapeutic efficacy (circulating tumor markers (e.g. CA 19-9), remission, relapse), chemotherapy-associated side effects (bone marrow suppression, neurotoxicity, mucositis and infectious complications such as sepsis, cholangitis), and (date of) death are collected. Primary outcome(s): Alpha diversity as a parameter for bacterial diversity in the fecal microbiota, analyzed at the time of initiation of chemotherapy treatment in newly diagnosed, locally advanced or metastatic PDAC, and the association with survival (follow-up up to max. 36 months). Study Design: Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: diagnostic

DISEASE(S): Pancreas, Unspecified

PROVIDER: 2437337 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR