The Role of Microbiota in Pancreatic Cancer and Precursor Lesions

NCT07250100 | Recruiting

• 1 other identifier: H-22019595
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Microbiome

Outcome Measures

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.

  2037

Secondary Outcomes (6)

• Databank

  2037

• Biobank

  2037

• Intratumor and gut mikrobiota

  2037

• Intratumor viral DNA

  2037

• Microbiome-tumor interaction

  2037

Study Arms (1)

Patients suspected of pancreatic cancer

Other: observational study

Interventions

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.

Patients suspected of pancreatic cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Contraindications for endoscopic or surgical procedure, such as uncorrected coagulopathy

Sponsors & Collaborators

• Herlev Hospital: lead
• Danish Cancer Society: collaborator

Study Sites (1)

Herlev og Gentofte Hospital

Herlev, Capital Region, 2730, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Pancreatic biopsies, oral swab, fekal swab

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Bojan Kovacevic, ph.d., MD

CONTACT

0045 3868 6312; bojan.kovacevic@regionh.dk

Louise Maegaard, MSc, RN

CONTACT

90045 3868 9879; louise.maegaard@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, ph.d.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): December 1, 2037
• Last Updated: November 26, 2025

Record last verified: 2025-10

Locations

DK (1)