Verification of Predictive Biomarkers for Pancreatic Cancer Treatment Using Multicenter Liquid Biopsy

September 27, 2022 updated by: Sang Myung Woo, National Cancer Center, Korea
This study is for verification of predictive biomarkers for pancreatic cancer treatment using multi-center liquid biopsy.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Clinical applicability of KRAS mutations using circulating-tumor DNA in pancreatic cancer patients.

  • Quantification and monitoring of KRAS mutations Using droplet digital PCR in ctDNA extracted from collected patient samples.
  • Correlation analysis of KRAS mutation results with clinical data.

Discovery of biomarkers for predicting pancreatic cancer prognosis through ctDNA panel.

  • Gene panel composition for pancreatic cancer therapeutic target determination and monitoring.
  • A panel was performed using gDNA and ctDNA of tumor tissue collected from pancreatic cancer patients.
  • Comparative analysis of panel results and quantitative KRAS mutations and evaluation of clinical applicability.

Study Type

Observational

Enrollment (Actual)

420

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu,

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Inpatient or outpatient

Description

Inclusion Criteria:

  • Patients with pathologically confirmed pancreatic adenocarcinoma.

Exclusion Criteria:

  • Patients disagree with the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical applicability of KRAS mutations
Time Frame: Locally advanced and Resectable patients: Pre Treatment, 1,2,3,6,9,12,15,18,21,24months/ Metastatic patients: Pre Treatment, 1,2,4,6,8,10,12,14,16,18,20,22,24 months
Clinical applicability of KRAS mutations using circulating-tumor DNA in pancreatic cancer patients.
Locally advanced and Resectable patients: Pre Treatment, 1,2,3,6,9,12,15,18,21,24months/ Metastatic patients: Pre Treatment, 1,2,4,6,8,10,12,14,16,18,20,22,24 months
Discovery of biomarkers through ctDNA panel
Time Frame: Locally advanced and Resectable patients: Pre Treatment, 1,2,3,6,9,12,15,18,21,24months/ Metastatic patients: Pre Treatment, 1,2,4,6,8,10,12,14,16,18,20,22,24 months
Discovery of biomarkers for predicting pancreatic cancer prognosis through ctDNA panel.
Locally advanced and Resectable patients: Pre Treatment, 1,2,3,6,9,12,15,18,21,24months/ Metastatic patients: Pre Treatment, 1,2,4,6,8,10,12,14,16,18,20,22,24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Sangmyung Woo, MD, National Cancer Center

Study record dates

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 Major Dates

Study Start (Actual)

March 28, 2019

Primary Completion (Actual)

June 3, 2021

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

January 22, 2020

First Submitted That Met QC Criteria

January 22, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC2019-0027

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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