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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03214991

Enrollment

100

Registered

2017-07-12

Start date

2017-05-12

Completion date

2021-03-31

Last updated

2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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
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
Overall survival rate (K-ras mutation type, EUS-FNA)	48 months	Overall survival rate according to K-ras mutation type in EUS-FNA specimen

Countries

South Korea

Contacts

Primary ContactYoung Hoon Choi, MD

crzyzs@naver.com82-2-2072-2228

Backup ContactJi Kon Ryu, MD, PhD

jkryu@snu.ac.kr82-2-2072-2228

Outcome results