Microbes linked to pancreatic cancer and early pancreatic lesions
The Role of Microbiota in Pancreatic Cancer and Precursor Lesions
This will see if microbes from the mouth, stool, and pancreas can help diagnose or predict outcomes for adults with suspected pancreatic lesions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Herlev Hospital Academic / other |
| Locations | 1 site (Herlev, Capital Region) |
| Trial ID | NCT07250100 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study enrolling adults with suspected solid or cystic pancreatic lesions who are undergoing diagnostic or therapeutic endoscopic procedures. Participants complete a questionnaire and provide oral and fecal swabs, and if clinically indicated clinicians will collect one or two pancreatic biopsies during standard care procedures. Collected samples will be analyzed for microbial composition and potential biomarkers and correlated with clinical findings and outcomes. The aims are to identify microbial signatures that improve diagnostic accuracy, inform prognosis, and help shape screening strategies for high-risk individuals.
Who should consider this trial
Good fit: Adults aged 18 or older with a suspected pancreatic lesion who are scheduled for a diagnostic or therapeutic endoscopic procedure and can give informed consent are eligible.
Not a fit: People without suspected pancreatic lesions or those who cannot undergo endoscopic or surgical procedures (for example due to uncorrected coagulopathy) are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the work could enable earlier or more accurate diagnosis and better prediction of treatment response for patients with pancreatic lesions.
How similar studies have performed: Previous research has found associations between microbiome patterns and pancreatic cancer, but microbial biomarkers are not yet established for routine clinical diagnosis or prognosis.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Herlev, Capital Region
- Herlev og Gentofte Hospital — Herlev, Capital Region, Denmark (Recruiting)
Study contacts
- Study coordinator: Bojan Kovacevic, ph.d., MD
- Email: bojan.kovacevic@regionh.dk
- Phone: 0045 3868 6312
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.