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

NCT05596370 | Unknown DMC

• 1 other identifier: H-2111-199-1281
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Pancreatic Cancer; Cholangiocarcinoma; Gallbladder Cancer

Keywords

cell-free nucleic acid; microbiome; biomarker

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

  the day of study enrollment and follow-up till end of the study

Study Arms (2)

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

Interventions

cell free DNA in blood and urine, metabolite/microbiome in urine and stool DIAGNOSTIC_TEST

cell free DNA in blood and urine, metabolite/microbiome in urine and stool

biliary cancer; pancreatic tumor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• DXOME CO., LTD.: collaborator

Study Sites (2)

Seoul National University Hospital

Seoul, 101, South Korea

RECRUITING

Sang Hyub Lee

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Cholangiocarcinoma; Gallbladder Neoplasms

Interventions

Blood Specimen Collection; Urination; Microbiota; Defecation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Biliary Tract Neoplasms; Biliary Tract Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Microbiological Phenomena; Biota; Biodiversity; Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 27, 2022
• Study Start: January 6, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)