The Role of Microbiota in Pancreatic Cancer and Precursor Lesions (MICROPAC)

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer; Microbiome
• Intervention / Treatment: Other: observational study

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Bojan Kovacevic, ph.d., MD; Phone Number: 0045 3868 6312; Email: bojan.kovacevic@regionh.dk
• Study Contact Backup: Name: Louise Maegaard, MSc, RN; Phone Number: 90045 3868 9879; Email: louise.maegaard@regionh.dk

Study Locations

• Denmark
  • Capital Region
    • Herlev, Capital Region, Denmark, 2730
      • Recruiting
      • Herlev og Gentofte Hospital
      • Contact: Bojan Kovacevic, MD, ph.d.; Phone Number: 0045 38686312; Email: bojan.kovacevic@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients suspected of pancreatic cancer	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2037

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Databank	To establish a databank containing clinical and demographic information from patients undergoing endoscopic evaluation of a pancreatic lesion	2037
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	2037
Intratumor and gut mikrobiota	To assess possible differences between intratumor and gut microbiota, and to inspect any changes in gut microbiota composition following surgery.	2037
Intratumor viral DNA	To investigate prevalence of intratumor viral DNA for the first time.	2037
Microbiome-tumor interaction	To elucidate microbiome-tumor interaction by examining intratumor gene expression and metabolism through RNA sequencing and isothermal microcalorimetry.	2037
Microbiome composition	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.	2037

Collaborators and Investigators

• Sponsor: Herlev Hospital
• Collaborators: Danish Cancer Society

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): December 1, 2037

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Investigative Techniques; Methods; Observation
• Other Study ID Numbers: H-22019595

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No