Cholangiocarcinoma, Gallbladder Cancer, Pancreatic Cancer
Conditions
Keywords
cell-free nucleic acid, microbiome, biomarker
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.
Interventions
DIAGNOSTIC_TESTcell 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
Sponsors
DXOME CO., LTD.
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed