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The Role of Microbiota in Pancreatic Cancer and Precursor Lesions

ConditionsPancreatic CancerMicrobiome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHerlev Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Contraindications for endoscopic or surgical procedure, such as uncorrected coagulopathy

Trial population

Adult patients at Herlev Hospital or Rigshospitalet, who meets the inclusion criteria

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • observational study

    Other intervention

    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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Patients suspected of pancreatic cancer1 intervention

Trial outcomes

Primary outcomes

1

Composition of microbiota in pancreatic cancer

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.

Time frame
2037

Secondary outcomes

1

Databank

To establish a databank containing clinical and demographic information from patients undergoing endoscopic evaluation of a pancreatic lesion

Time frame
2037
2

Biobank

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

Time frame
2037
3

Intratumor and gut mikrobiota

To assess possible differences between intratumor and gut microbiota, and to inspect any changes in gut microbiota composition following surgery.

Time frame
2037
4

Intratumor viral DNA

To investigate prevalence of intratumor viral DNA for the first time.

Time frame
2037

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Herlev Hospital

Lead sponsor

Danish Cancer Society

Collaborator

Source ClinicalTrials.gov
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