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Trial Title:
Association Between Cell-free Nucleic Acid in Blood, Urine and Microbiome in Stool With Pancreatobiliary Cancer
NCT ID:
NCT05596370
Condition:
Pancreatic Cancer
Cholangiocarcinoma
Gallbladder Cancer
Conditions: Official terms:
Cholangiocarcinoma
Gallbladder Neoplasms
Conditions: Keywords:
cell-free nucleic acid
microbiome
biomarker
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
cell free DNA in blood and urine, metabolite/microbiome in urine and stool
Description:
cell free DNA in blood and urine, metabolite/microbiome in urine and stool
Arm group label:
biliary cancer
Arm group label:
pancreatic tumor
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
101
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Sang Hyub Lee, MD PhD
Phone:
01087036267
Email:
gidoctor@snu.ac.kr
Investigator:
Last name:
Sang Hyub Lee, MD PhD
Email:
Principal Investigator
Investigator:
Last name:
Jin Ho Choi, MD
Email:
Sub-Investigator
Facility:
Name:
Sang Hyub Lee
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Sang Hyub Lee, MD., PhD
Phone:
+82-2-2072-2228
Email:
gidoctor@snu.ac.kr
Investigator:
Last name:
Jin Ho Choi, MD
Email:
Sub-Investigator
Start date:
January 6, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Seoul National University Hospital
Agency class:
Other
Collaborator:
Agency:
DXOME CO., LTD.
Agency class:
Other
Source:
Seoul National University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05596370
