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| Name | Class |
|---|---|
| DXOME CO., LTD. | UNKNOWN |
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Based on the cell free nucleic acid analysis information of blood samples, the results of microbiome and metabolite analysis of stool and urine samples of pancreatic cancer and bile duct cancer patients, the clinical correlations of them with primary cancer are evaluated. And based on these information, biomarkers for diagnosis, treatment, and prognosis of pancreatic and bile duct cancer are explored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| biliary cancer | cholangiocarcinoma gallbladder cancer |
| |
| pancreatic tumor | pancreatic cancer pancreatic ductal adenocarcinoma pancreatic neuroendocrine tumor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cell free DNA in blood and urine, metabolite/microbiome in urine and stool | Diagnostic Test | cell free DNA in blood and urine, metabolite/microbiome in urine and stool |
|
| Measure | Description | Time Frame |
|---|---|---|
| correlation of genetic mutation | concordance of genetic mutation between tissue and blood of treatment-naive status | the day of study enrollment or the day of tissue and blood acquisition |
| correlation of genetic mutation burden and prognosis | correlation of genetic mutation burden and prognosis | the day of study enrollment and follow-up till end of the study |
| Measure | Description | Time Frame |
|---|---|---|
| correlation of metabolic change in urine metabolite and prognosis | analysis of correlation of metabolic change in urine metabolite and prognosis | the day of study enrollment and follow-up till end of the study |
| correlation of microbiome in stool and prognosis |
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Inclusion Criteria:
Exclusion Criteria:
Where the subject himself/herself refuses to fill out the consent form or is unable to fill out the consent form
In the case where the sample storage conditions suggested by the reagent manufacturer are not satisfied
Only samples that can cause errors when determining results are acquired:
Heat treated specimen
Incompletely coagulated serum and bacterial samples â‘¢ Samples with particulate matter elements (e.g., fibroblasts, red blood cells) remaining in the sample
â‘£ Specimens previously frozen and stored with blood clots that have confirmed an increase in non-specific reactivity in which samples appear to have denatured during storage
⑤ Sample from deceased patient
â‘¥ A patient specimen with a malignancy of ohter site
⑦ Sample from vulnerable persons such as pregnant women, minors, etc
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Patients aged 18 or older, who diagnosed with pancreatic cancer or biliary tract cancer (cholangiocarcinoma, gallbladder cancer) through histological or radiologic examination and before treatment begins
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 101 | South Korea |
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analysis of correlation of microbiome in stool and prognosis |
| the day of study enrollment and follow-up till end of the study |
| Sang Hyub Lee | Recruiting | Seoul | South Korea |
|
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D018281 | Cholangiocarcinoma |
| D005706 | Gallbladder Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D001661 | Biliary Tract Neoplasms |
| D001660 | Biliary Tract Diseases |
| D005705 | Gallbladder Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D014554 | Urination |
| D064307 | Microbiota |
| D003672 | Defecation |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D014553 | Urinary Tract Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D008827 | Microbiological Phenomena |
| D058448 | Biota |
| D044822 | Biodiversity |
| D017753 | Ecosystem |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D004778 | Environment and Public Health |
| D004068 | Digestive System Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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