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2022-01-06
2024-12-31
2024-12-31
150
NCT05596370
Seoul National University Hospital
Seoul National University Hospital
OBSERVATIONAL
Association Between Cell-free Nucleic Acid in Blood, Urine and Microbiome in Stool With Pancreatobiliary Cancer
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-10-24 | N/A | 2022-11-02 |
2022-10-24 | N/A | 2022-11-07 |
2022-10-27 | N/A | 2022-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : biliary cancer cholangiocarcinoma gallbladder cancer | DIAGNOSTIC_TEST: 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
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
