The Role of Microbiota in Pancreatic Cancer and Precursor Lesions

NCT ID: NCT07250100

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-01

Study Completion Date

2037-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Cancer Microbiome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients suspected of pancreatic cancer

observational study

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Cancer Society

OTHER

Sponsor Role collaborator

Herlev Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bojan Kovacevic

MD, ph.d.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Herlev og Gentofte Hospital

Herlev, Capital Region, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Bojan Kovacevic, ph.d., MD

Role: CONTACT

0045 3868 6312

Louise Maegaard, MSc, RN

Role: CONTACT

90045 3868 9879

Facility Contacts

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Bojan Kovacevic, MD, ph.d.

Role: primary

0045 38686312

Other Identifiers

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H-22019595

Identifier Type: -

Identifier Source: org_study_id

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