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Clinical Trials/NCT03214991
NCT03214991
Unknown
Not Applicable

Circulating Tumor DNA as a Prognostic Marker in Patients With Pancreatic Cancer

Ji Kon Ryu1 site in 1 country100 target enrollmentMay 12, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pancreatic Cancer
Sponsor
Ji Kon Ryu
Enrollment
100
Locations
1
Primary Endpoint
Overall survival rate
Last Updated
8 years ago

Overview

Brief Summary

The aim of this study is to determine the usefulness of circulating tumor DNA as a prognostic factor in patients with pancreatic cancer.

Detailed Description

There is currently no strong prognostic factor in pancreatic cancer. K-ras is the most commonly mutated gene in pancreatic cancer, with a mutation rate of 75% to 95%. These high mutation rates are expected to be useful for diagnosis and prognostic factors in future. Currently, K-ras mutation tests are often performed in tissues, and there are various limitations, in particular, limited obtaining of sufficient tissues. In this regard, analyzing the prognosis of pancreatic cancer through non-invasive blood testing has significant advantages. And Prognosis analysis through blood tests can be done through blood circulating tumor DNA. The relationship between prognosis and blood circulating tumor DNA has already been studied in other cancers such as colorectal cancer, and there have been several studies in pancreatic cancer. However, there are not many research results yet, and there are cases in which the results differ from study to study. Therefore, the purpose of this study is to compare the overall survival of patients with pancreatic cancer diagnosed by EUS-FNA according to the presence and amount of blood circulating tumor DNA with K-ras mutation.

Registry
clinicaltrials.gov
Start Date
May 12, 2017
End Date
March 31, 2021
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Ji Kon Ryu
Responsible Party
Sponsor Investigator
Principal Investigator

Ji Kon Ryu

Professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients diagnosed with pancreatic cancer through EUS-FNA.

Exclusion Criteria

  • Severe mental illness
  • Severe co-morbidity (ESRD, Advanced COPD, severe Heart failure, poorly controlled blood sugar)
  • Pregnancy
  • Patients who have received chemotherapy
  • Coagulopathy

Outcomes

Primary Outcomes

Overall survival rate

Time Frame: 48 months

Comparison of overall survival rates between patients with and without blood-circulating tumor DNA

Secondary Outcomes

  • Overall survival rate according to the amount of blood circulating tumor DNA(48mo)
  • K-ras mutation(48 months)
  • Overall survival rate (EUS-FNA)(48 months)
  • Overall survival rate (K-ras mutation type, circulating tumor DNA)(48 months)
  • Overall survival rate (K-ras mutation type, EUS-FNA)(48 months)

Study Sites (1)

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