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

NCT ID: NCT03214991

Last Updated: 2018-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-12

Study Completion Date

2021-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ji Kon Ryu

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ji Kon Ryu

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ji Kon Ryu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Young Hoon Choi, MD

Role: CONTACT

82-2-2072-2228

Ji Kon Ryu, MD, PhD

Role: CONTACT

82-2-2072-2228

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Young Hoon Choi, MD

Role: primary

82-2-2072-2228

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1704-108-847

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cohort Study of Pancreatic Cancer Risk
NCT04247503 ACTIVE_NOT_RECRUITING