The Role of Microbiota in Pancreatic Cancer and Precursor Lesions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: observational study.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer, Microbiome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other observational 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.
Primary outcome measures
- Composition of microbiota in pancreatic cancer [Time frame: 2037]
Secondary outcome measures (6)
- Databank [Time frame: 2037]
- Biobank [Time frame: 2037]
- Intratumor and gut mikrobiota [Time frame: 2037]
- Intratumor viral DNA [Time frame: 2037]
- Microbiome-tumor interaction [Time frame: 2037]
- Microbiome composition [Time frame: 2037]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Herlev og Gentofte Hospital — Herlev
Identifiers
NCT: NCT07250100 · H-22019595