Clinical trial NCT05596370: Association Between Cell-free Nucleic Acid in Blood, Urine and Microbiome in Stool With Pancreatobiliary Cancer
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Cancer
Cholangiocarcinoma
Gallbladder Cancer
Keywords: cell-free nucleic acid
microbiome
biomarker
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: DXOME CO., LTD.
First posted: 2022-10-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: correlation of genetic mutation
timeFrame: the day of study enrollment or the day of tissue and blood acquisition
measure: correlation of genetic mutation burden and prognosis
timeFrame: the day of study enrollment and follow-up till end of the study
Secondary outcomes:
measure: correlation of metabolic change in urine metabolite and prognosis
timeFrame: the day of study enrollment and follow-up till end of the study
measure: correlation of microbiome in stool and prognosis
timeFrame: the day of study enrollment and follow-up till end of the study
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Sang Hyub Lee
Study officials:
References: