Association Between Cell-free Nucleic Acid in Blood, Urine and Microbiome in Stool With Pancreatobiliary Cancer

Study Overview
=================
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.

Official Title
-----------------
Confirmation of Association Between Cell-free Nucleic Acid in Blood and Urine Samples and Microbiome in Stool With Pancreatobiliary Cancer and Study Related to Exploration of Biomarkers in Diagnosis and Treatment of Pancreatobiliary Cancers

Conditions
-----------------
Pancreatic Cancer, Cholangiocarcinoma, Gallbladder Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: cell free DNA in blood and urine, metabolite/microbiome in urine and stool


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| biliary cancer<br>cholangiocarcinoma gallbladder cancer | Diagnostic Test: cell free DNA in blood and urine, metabolite/microbiome in urine and stool<br>* cell free DNA in blood and urine, metabolite/microbiome in urine and stool<br>|
| pancreatic tumor<br>pancreatic cancer pancreatic ductal adenocarcinoma pancreatic neuroendocrine tumor | Diagnostic Test: cell free DNA in blood and urine, metabolite/microbiome in urine and stool<br>* cell free DNA in blood and urine, metabolite/microbiome in urine and stool<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | analysis of correlation of microbiome in stool and prognosis | the day of study enrollment and follow-up till end of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cell-free nucleic acid, microbiome, biomarker