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NCT Number: NCT07250100

The Role of Microbiota in Pancreatic Cancer and Precursor Lesions

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Microbiome Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herlev og Gentofte Hospital

Herlev, Capital Region, 2730, Denmark

Location status: Recruiting

Location contact

Bojan Kovacevic, MD, ph.d.

CONTACT

[email protected]

0045 38686312

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observational study

Other

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 outcomes

  1. Composition of microbiota in pancreatic cancer

    Time frame: 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 outcomes

  1. Databank

    Time frame: 2037

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

  2. Biobank

    Time frame: 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

  3. Intratumor and gut mikrobiota

    Time frame: 2037

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

  4. Intratumor viral DNA

    Time frame: 2037

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

  5. Microbiome-tumor interaction

    Time frame: 2037

    To elucidate microbiome-tumor interaction by examining intratumor gene expression and metabolism through RNA sequencing and isothermal microcalorimetry.

  6. Microbiome composition

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bojan Kovacevic, ph.d., MD

CONTACT

[email protected]

0045 3868 6312

Louise Maegaard, MSc, RN

CONTACT

[email protected]

90045 3868 9879

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Collaborators

  • Danish Cancer Society

Registry information

Acronym: MICROPAC

Important dates

Study start
2025
Primary completion
2030
Study completion
2037
First posted
Nov 26, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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