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| Name | Class |
|---|---|
| Danish Cancer Society | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients suspected of pancreatic cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Databank | To establish a databank containing clinical and demographic information from patients undergoing endoscopic evaluation of a pancreatic lesion | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients at Herlev Hospital or Rigshospitalet, who meets the inclusion criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev og Gentofte Hospital | Recruiting | Herlev | Capital Region | 2730 | Denmark |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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Pancreatic biopsies, oral swab, fekal swab
|
| 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. | 2037 |
| Intratumor viral DNA | To investigate prevalence of intratumor viral DNA for the first time. | 2037 |
| Microbiome-tumor interaction | To elucidate microbiome-tumor interaction by examining intratumor gene expression and metabolism through RNA sequencing and isothermal microcalorimetry. | 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. | 2037 |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |