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

Active, not recruiting

• Conditions: Pancreas Adenocarcinoma

• Registration Number: NCT04241367
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

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 Timeline

• Study Start: 2019-03-28
• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2020-01-22
• Study First Posted: 2020-01-27
• Primary Completion: 2021-06-03
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-29
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

• Patients with pathologically confirmed pancreatic adenocarcinoma.

Exclusion Criteria

• Patients disagree with the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical applicability of KRAS mutations	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	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.

Trial Locations

Locations (1)

NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu,; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of