Clincosm LogoSign in Get a demo

A Longitudinal, Observational Biomarker Study in Pancreatic Cancer Patients Receiving Chemotherapy

Sponsor
National Cancer Center, Korea (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04281511
Collaborator
(none)
238
Enrollment
1
Location
56.9
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

  1. Based on the literature, the pancreatic cancer treatment predictor biomarker, which is used in the domestic clinical field, is actually applied to the pancreatic cancer patient cohort of the National Cancer Center.

  2. To systematically prospectively identify prospective treatment response biomarkers for Pancreatic Cancer Cohort in the National Cancer Center

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    1. Immunohistochemistry and gene test for hENT1, DCK, SMAD4, CES2, BRCA 1/2,PALB2, MMRd, MSI, Tumor Ag and etc. on Cancer sample

    2. Collect data of Biomarker for pancreatic cancer

    3. Compare with Big data and Cohort study in National cancer center

    4. The number of subjects is changed by statistical consideration. 218->238

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    238 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Longitudinal, Observational Biomarker Study in Pancreatic Cancer Patients Receiving Chemotherapy
    Actual Study Start Date :
    Apr 3, 2019
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. median survival [5 years]

      The length of time from either the date of diagnosis or the start of treatment for a disease,the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse

    2. progressive-free survival [5 years]

      The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Pathologically Confirmed Pancreatic Cancer Patients
    Exclusion Criteria:
    • Subjects who do not agree 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 10408

    Sponsors and Collaborators

    • National Cancer Center, Korea

    Investigators

    • Principal Investigator: Sangmyung Woo, 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:
    NCT04281511
    Other Study ID Numbers:
    • NCC2019-0034
    First Posted:
    Feb 24, 2020
    Last Update Posted:
    Apr 21, 2021
    Last Verified:
    Apr 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
    Pancreatic cancer
    Biomarker
    chemotherapy
    pharmacogenomic
    clinical trials
    Additional relevant MeSH terms:
    Pancreatic Neoplasms

    Study Results

    No Results Posted as of Apr 21, 2021