Microbiome, Pancreatic Cancer
Conditions
Brief summary
This is a prospective observational study aiming to investigate the microbiome in patients suspected of having pancreatic cancer. The purpose is to enhance diagnostic accuracy by developing screening protocols for high-risk individuals, identifying specific microbial biomarkers, and improving prognostic criteria to optimize treatment response. Participants will be asked to complete a questionnaire, provide oral and fecal swabs, and-if clinically indicated-1-2 pancreatic biopsies will be collected.
Interventions
OTHERobservational study
Aprox. 300 patients suspected of pancreatic cancer. Of those, minimum of 50 patients with histologically confirmed PDAC in each of the stages I-II, III and IV, as some of the participants will be diagnosed with a non-malignant disease and will constitute the control group.
Sponsors
Danish Cancer Society
Herlev Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a suspected lesion (solid/cystic) in the pancreas undergoing diagnostic or therapeutic endoscopic procedure * Age of 18 years or above * Signed informed consent form
Exclusion criteria
* Contraindications for endoscopic or surgical procedure, such as uncorrected coagulopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composition of microbiota in pancreatic cancer | 2037 | To examine the composition of microbiota in pancreatic cancer and its precursors, to explore association between bacterial/fungal genera and final diagnosis, survival and risk of recurrence, but also to examine a possible role of microbiota in development of surgical adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiome-tumor interaction | 2037 | To elucidate microbiome-tumor interaction by examining intratumor gene expression and metabolism through RNA sequencing and isothermal microcalorimetry. |
| Databank | 2037 | To establish a databank containing clinical and demographic information from patients undergoing endoscopic evaluation of a pancreatic lesion |
| Biobank | 2037 | To establish a biobank of various biological material, herein tissue biopsies and/or cyst fluid, oral and fecal swabs at the time of inclusion and following end of therapy |
| Intratumor and gut mikrobiota | 2037 | To assess possible differences between intratumor and gut microbiota, and to inspect any changes in gut microbiota composition following surgery. |
| Intratumor viral DNA | 2037 | To investigate prevalence of intratumor viral DNA for the first time. |
| Microbiome composition | 2037 | To visualize microbiome composition within the tumor through fluorescence in situ hybridization confocal laser scanning microscopy and to determine geographic spread of the microbiome and its interaction with tumor cells. |
Countries
Denmark
Contacts
Primary ContactBojan Kovacevic, ph.d., MD
Backup ContactLouise Maegaard, MSc, RN
Outcome results
None listed