2017-05-12
2020-09-30
2021-03-31
100
NCT03214991
Seoul National University Hospital
Seoul National University Hospital
OBSERVATIONAL
Circulating Tumor DNA as a Prognostic Marker in Patients With Pancreatic Cancer
The aim of this study is to determine the usefulness of circulating tumor DNA as a prognostic factor in patients with pancreatic cancer.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2017-07-11 | N/A | 2018-02-01 |
2017-07-11 | N/A | 2018-02-05 |
2017-07-12 | N/A | 2018-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Overall survival rate | Comparison of overall survival rates between patients with and without blood-circulating tumor DNA | 48 months |
Secondary Outcome Measures | Measure Description | Time Frame |
---|---|---|
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 |
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 |
Overall survival rate (EUS-FNA) | Overall survival rate with or without K-ras mutation of EUS-FNA specimen | 48 months |
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 |
Overall survival rate (K-ras mutation type, EUS-FNA) | Overall survival rate according to K-ras mutation type in EUS-FNA specimen | 48 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact Name: Young Hoon Choi, MD Phone Number: 82-2-2072-2228 Email: crzyzs@naver.com |
Study Contact Backup Name: Ji Kon Ryu, MD, PhD Phone Number: 82-2-2072-2228 Email: jkryu@snu.ac.kr |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.