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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03214991
• Other study ID #: 1704-108-847
• Status: Recruiting
• Phase: N/A
• First received: July 11, 2017
• Last updated: February 1, 2018
• Start date: May 12, 2017
• Est. completion date: March 31, 2021

Study information

• Verified date: February 2018
• Source: Seoul National University Hospital
• Contact: Young Hoon Choi, MD
• Phone: 82-2-2072-2228
• Email: crzyzs[@]naver.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Ji Kon Ryu

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival rate	Comparison of overall survival rates between patients with and without blood-circulating tumor DNA	48 months
Secondary	Overall survival rate according to the amount of blood circulating tumor DNA	Overall survival rate according to the amount of blood circulating tumor DNA	48mo
Secondary	K-ras mutation	The concordance rate of K-ras mutation in EUS-FNA specimen and K-ras mutation in blood circulating tumor DNA	48 months
Secondary	Overall survival rate (EUS-FNA)	Overall survival rate with or without K-ras mutation of EUS-FNA specimen	48 months
Secondary	Overall survival rate (K-ras mutation type, circulating tumor DNA)	Overall survival rate according to K-ras mutation type in blood circulating tumor DNA	48 months
Secondary	Overall survival rate (K-ras mutation type, EUS-FNA)	Overall survival rate according to K-ras mutation type in EUS-FNA specimen	48 months