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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05596370
• Other study ID #: H-2111-199-1281
• Status: Recruiting
• Start date: January 6, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ? Samples with particulate matter elements (e.g., fibroblasts, red blood cells) remaining in the sample

? 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

? Sample from deceased patient

? A patient specimen with a malignancy of ohter site

? Sample from vulnerable persons such as pregnant women, minors, etc

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Gallbladder Cancer
• Gallbladder Neoplasms
• Pancreatic Cancer

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Sang Hyub Lee	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	DXOME CO., LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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