Pancreas AdenocarcinomaNCT04241367
Verification of Predictive Biomarkers for Pancreatic Cancer Treatment Using Multicenter Liquid Biopsy
An observational study of Pancreas Adenocarcinoma, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
This study is for verification of predictive biomarkers for pancreatic cancer treatment using multi-center liquid biopsy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreas Adenocarcinoma
- How many people
- 420 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Mar 2019to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inpatient or outpatient
Who may be able to join
- Patients with pathologically confirmed pancreatic adenocarcinoma.
Who cannot join
- Patients disagree with the study.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu,
Goyang-si, Gyeonggi-do, 410-769
About this study
This study is for verification of predictive biomarkers for pancreatic cancer treatment using multi-center liquid biopsy.
Read the 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.
- Conditions
- Pancreas Adenocarcinoma
- Keywords
- Pancreas Adenocarcinoma, Circulating-tumor DNA, KRAS mutations, Cancer Panel, Prognostic markers
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical applicability of KRAS mutations
Clinical applicability of KRAS mutations using circulating-tumor DNA in pancreatic cancer patients.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start28 Mar 2019
- Primary completion3 Jun 2021
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreas AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sang Myung Woo, National Cancer Center, Korea
- Investigators
- Sangmyung Woo, MD, Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241367
- Sponsor's protocol ID
- NCC2019-0027
- Status last verified
- Jun 2025
- First submitted
- 22 Jan 2020
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40509918
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of Predictive Biomarkers for Pancreatic Cancer Treatment Using Multicenter Liquid Biopsy
- ClinicalTrials.gov ID
- NCT04241367
- Acronym / sponsor ID
- NCC2019-0027
- Conditions
- Pancreas Adenocarcinoma
- Keywords
- Pancreas Adenocarcinoma, Circulating-tumor DNA, KRAS mutations, Cancer Panel, Prognostic markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 3 Jun 2021 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is for verification of predictive biomarkers for pancreatic cancer treatment using multi-center liquid biopsy.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inpatient or outpatient
Key inclusion criteria (1 listed)
- Patients with pathologically confirmed pancreatic adenocarcinoma.
Key exclusion criteria (1 listed)
- Patients disagree with the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Derived from this study: PubMed 40509918Chun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sangmyung Woo, MD principal investigator
National Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Adenocarcinoma, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04241367, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.