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

Sponsor
National Cancer Center, Korea (Other)
Overall Status
Recruiting
CT.gov ID
NCT04241367
Collaborator
(none)
420
Enrollment
1
Location
81.1
Anticipated Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    420 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Verification of Predictive Biomarkers for Pancreatic Cancer Treatment Using Multicenter Liquid Biopsy
    Actual Study Start Date :
    Mar 28, 2019
    Actual Primary Completion Date :
    Jun 3, 2021
    Anticipated Study Completion Date :
    Dec 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with pathologically confirmed pancreatic adenocarcinoma.
    Exclusion Criteria:
    • Patients disagree with the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu, Goyang-si Gyeonggi-do Korea, Republic of 410-769

    Sponsors and Collaborators

    • National Cancer Center, Korea

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sang Myung Woo, Chief, Senior Scientist, National Cancer Center, Korea
    ClinicalTrials.gov Identifier:
    NCT04241367
    Other Study ID Numbers:
    • NCC2019-0027
    First Posted:
    Jan 27, 2020
    Last Update Posted:
    Sep 1, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sang Myung Woo, Chief, Senior Scientist, National Cancer Center, Korea
    Pancreas Adenocarcinoma
    Circulating-tumor DNA
    KRAS mutations
    Cancer Panel
    Prognostic markers
    Additional relevant MeSH terms:
    Adenocarcinoma

    Study Results

    No Results Posted as of Sep 1, 2021