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

NCT ID: NCT05596370

Last Updated: 2022-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-06

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Cancer Cholangiocarcinoma Gallbladder Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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biliary cancer

cholangiocarcinoma gallbladder cancer

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

Intervention Type 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

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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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DXOME CO., LTD.

UNKNOWN

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sang Hyub Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Sang Hyub Lee

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Sang Hyub Lee, MD PhD

Role: primary

01087036267

Sang Hyub Lee, MD., PhD

Role: primary

+82-2-2072-2228

Other Identifiers

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H-2111-199-1281

Identifier Type: -

Identifier Source: org_study_id

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