DNA Mutation Detection in Circulating Tumor DNA and Tissue by mmADPS for Pancreatic Cancer

Study Overview
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Brief Summary
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Based on the cell free nucleic acid analysis information of blood samples and genetic mutation profile of EUS-FNB tissue from pancreatic cancer, the concordance between them is evaluated. And based on this information, biomarkers for diagnosis, treatment, and prognosis of pancreatic cancer are explored.

Official Title
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DNA Mutation Detection in Circulating Tumor DNA and Tissue by Massive Multiplex Allele Discrimination Priming System(mmADPS) for Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Diagnostic Test: cell free DNA in blood, genetic mutation in tissue


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with pancreatic 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 Among patients diagnosed with benign pancreatic diseases (pancreatic cyst, chronic pancreatitis, etc.), patients who have need for histological examination as control group Exclusion Criteria: Where the subject himself/herself refuses to fill out the consent form or is unable to fill out the consent form If a laboratory test is impossible due to a qualitative problem with the collected blood sample Where the collected tissue does not contain tissue of the desired malignant or benign disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pancreatic cancer<br>patients with pancreatic cancer | Diagnostic Test: cell free DNA in blood, genetic mutation in tissue<br>* Diagnostic test for cell free DNA in blood, genetic mutation in tissue<br>|
| control<br>patients without any malignancy | Diagnostic Test: cell free DNA in blood, genetic mutation in tissue<br>* Diagnostic test for cell free DNA in blood, genetic mutation in tissue<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation of genetic mutation | concordance of genetic mutation between tissue and blood of treatment-naive status | the day of study enrollment (baseline) | 
| detection sensitivity of genetic mutation by mmADPS | detection sensitivity of genetic mutation by mmADPS | the day of study enrollment (baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation of genetic mutation and prognosis | correlation of genetic mutation and prognosis | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic cancer, Circulating Tumor DNA, DNA mutation, DNA methylation