NCT04241367

Brief Summary

This study is for verification of predictive biomarkers for pancreatic cancer treatment using multi-center liquid biopsy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2021

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 9, 2026

Status Verified

June 1, 2025

Enrollment Period

2.2 years

First QC Date

January 22, 2020

Last Update Submit

April 6, 2026

Conditions

Pancreas Adenocarcinoma

Keywords

Pancreas AdenocarcinomaCirculating-tumor DNAKRAS mutationsCancer PanelPrognostic markers

Outcome Measures

Primary Outcomes (2)

  • Clinical applicability of KRAS mutations

    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

    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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Inpatient or outpatient

You may qualify if:

  • Patients with pathologically confirmed pancreatic adenocarcinoma.

You may not qualify if:

  • Patients disagree with the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu,

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Related Publications (1)

  • Chun JW, Lee DE, Kim MK, Hwang JH, Lee SH, Jung MK, Kim EJ, Ahn DW, Kim YH, Han SS, Park SJ, Lee WJ, Woo SM, Kong SY. Optimal Value of Mutant KRAS Circulating Tumor DNA for Predicting Prognosis and Monitoring in Patients with Pancreatic Adenocarcinoma: A Prospective Multicenter Cohort Study. Clin Chem. 2025 Sep 3;71(9):993-1004. doi: 10.1093/clinchem/hvaf066.

    PMID: 40509918DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

Study Officials

  • Sangmyung Woo, MD

    National Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Senior Scientist

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 27, 2020

Study Start

March 28, 2019

Primary Completion

June 3, 2021

Study Completion

December 31, 2025

Last Updated

April 9, 2026

Record last verified: 2025-06

Locations

KR(1)