Pancreatic CancerMICROPACNCT07250100
The Role of Microbiota in Pancreatic Cancer and Precursor Lesions
An observational study of Pancreatic Cancer and Microbiome, run by Herlev Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Microbiome
- What is being tested?
- observational study
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2025to Dec 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients at Herlev Hospital or Rigshospitalet, who meets the inclusion criteria
Who may be able to join
- 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
Who cannot join
- Contraindications for endoscopic or surgical procedure, such as uncorrected coagulopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Herlev og Gentofte Hospital
Herlev, Capital Region, 2730
Bojan Kovacevic, MD, ph.d., 0045 38686312, bojan.kovacevic@regionh.dk
About this study
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
- Being tested
- observational study
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients suspected of pancreatic cancer | Not described Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2037
Secondary outcomes (6)
Databank
To establish a databank containing clinical and demographic information from patients undergoing endoscopic evaluation of a pancreatic lesion
Measured: 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
Measured: 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.
Measured: 2037
Intratumor viral DNA
To investigate prevalence of intratumor viral DNA for the first time.
Measured: 2037
Microbiome-tumor interaction
To elucidate microbiome-tumor interaction by examining intratumor gene expression and metabolism through RNA sequencing and isothermal microcalorimetry.
Measured: 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.
Measured: 2037
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Nov 2025
- Primary completionOct 2030 (estimated)
- Study completionDec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Principal investigator, Bojan Kovacevic, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250100
- Sponsor's protocol ID
- H-22019595
- Acronym
- MICROPAC
- Status last verified
- Oct 2025
- First submitted
- 18 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Microbiota in Pancreatic Cancer and Precursor Lesions
- ClinicalTrials.gov ID
- NCT07250100
- Acronym / sponsor ID
- MICROPAC / H-22019595
- Conditions
- Pancreatic Cancer, Microbiome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Dec 2037 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients suspected of pancreatic cancer | – | Other: observational study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients at Herlev Hospital or Rigshospitalet, who meets the inclusion criteria
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Contraindications for endoscopic or surgical procedure, such as uncorrected coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational studyAprox. 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. | Other | Patients suspected of pancreatic cancer |
Primary outcome
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.
6 secondary outcomes
Databank
Time frame: 2037
Biobank
Time frame: 2037
Intratumor and gut mikrobiota
Time frame: 2037
Intratumor viral DNA
Time frame: 2037
Microbiome-tumor interaction
Time frame: 2037
Microbiome composition
Time frame: 2037
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Microbiome, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bojan Kovacevic, ph.d., MD (0045 3868 6312, bojan.kovacevic@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composition of microbiota in pancreatic cancer (time frame: 2037). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.