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

Pancreas Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04241367
• Other study ID #: NCC2019-0027
• Status: Active, not recruiting
• Start date: March 28, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2022
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 420
• Est. completion date: December 31, 2025
• Est. primary completion date: June 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with pathologically confirmed pancreatic adenocarcinoma.

Exclusion Criteria:

• Patients disagree with the study.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreas Adenocarcinoma

Locations

Country	Name	City	State
Korea, Republic of	NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu,	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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