Association Between Cell-free Nucleic Acid in Blood, Urine and Microbiome in Stool With Pancreatobiliary Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| biliary cancer cholangiocarcinoma gallbladder cancer |
Diagnostic Test: cell free DNA in blood and urine, metabolite/microbiome in urine and stool
cell free DNA in blood and urine, metabolite/microbiome in urine and stool
|
| pancreatic tumor pancreatic cancer pancreatic ductal adenocarcinoma pancreatic neuroendocrine tumor |
Diagnostic Test: cell free DNA in blood and urine, metabolite/microbiome in urine and stool
cell free DNA in blood and urine, metabolite/microbiome in urine and stool
|
Outcome Measures
Primary Outcome Measures
- correlation of genetic mutation [the day of study enrollment or the day of tissue and blood acquisition]
concordance of genetic mutation between tissue and blood of treatment-naive status
- correlation of genetic mutation burden and prognosis [the day of study enrollment and follow-up till end of the study]
correlation of genetic mutation burden and prognosis
Secondary Outcome Measures
- correlation of metabolic change in urine metabolite and prognosis [the day of study enrollment and follow-up till end of the study]
analysis of correlation of metabolic change in urine metabolite and prognosis
- correlation of microbiome in stool and prognosis [the day of study enrollment and follow-up till end of the study]
analysis of correlation of microbiome in stool and prognosis
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients diagnosed with pancreatic cancer through histological or radiologic examination and before treatment begins
-
Patients diagnosed with biliary tract cancer (cholangiocarcinoma, gallbladder cancer) through histological or radiologic examination and before treatment begins
-
Patients aged 18 or older who voluntarily agrees to participate in the study and is willing to understand and comply with the subsequent treatment procedures and sample collection schedule
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 ③ Samples with particulate matter elements (e.g., fibroblasts, red blood cells) remaining in the sample
④ 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
⑥ A patient specimen with a malignancy of ohter site
⑦ Sample from vulnerable persons such as pregnant women, minors, etc
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital | Seoul | Korea, Republic of | 101 | |
| 2 | Sang Hyub Lee | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Seoul National University Hospital
- DXOME CO., LTD.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-2111-199-1281