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

• Conditions: Pancreatic Cancer

• Registration Number: NCT03214991
• Lead Sponsor: Ji Kon Ryu

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.

Study Timeline

• Study Start: 2017-05-12
• Study First Submitted: 2017-07-11
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-01
• Last Update Posted: 2018-02-05
• Primary Completion: 2020-09-30
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival rate	48 months	Comparison of overall survival rates between patients with and without blood-circulating tumor DNA

Secondary Outcome Measures

Name	Time	Method
Overall survival rate according to the amount of blood circulating tumor DNA	48mo	Overall survival rate according to the amount of blood circulating tumor DNA
Overall survival rate (K-ras mutation type, EUS-FNA)	48 months	Overall survival rate according to K-ras mutation type in EUS-FNA specimen
K-ras mutation	48 months	The concordance rate of K-ras mutation in EUS-FNA specimen and K-ras mutation in blood circulating tumor DNA
Overall survival rate (EUS-FNA)	48 months	Overall survival rate with or without K-ras mutation of EUS-FNA specimen
Overall survival rate (K-ras mutation type, circulating tumor DNA)	48 months	Overall survival rate according to K-ras mutation type in blood circulating tumor DNA

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of