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Prospective Trial for the Evaluation of Radiogenomics in Advanced Rectal Cancer

Sponsor
National Cancer Center, Korea (Other)
Overall Status
Recruiting
CT.gov ID
NCT04287400
Collaborator
(none)
210
Enrollment
1
Location
80.9
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In patients with advanced rectal cancer, molecular subtypes will be identified by preoperative biopsy, CT, MRI / PET radiomics analysis, clinical features, and clinical features will be confirmed and compared.

Also, we want to confirm the relationship between these factors and the treatment response after chemoradiotherapy before surgery. The prognosis will be then assessed through 5-year overall survival and 3-year disease free survival.

A prospective clinical trial, recruiting 210 persons (approximately 53 per year) that meet the selection criteria for approximately four years from the IRB approval date in 2019 (about 53 per year) We will analyze the data and then collect and analyze the data and report the results.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    210 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Clinical Trial for the Evaluation of Radiogenomics: Correlation, Treatment Response and Prognosis in Patients With Advanced Rectal Cancer, Who Undergo Preoperative Chemoradiation
    Actual Study Start Date :
    Mar 5, 2019
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. K-RAS Mutation [4 weeks]

      K-RAS Mutation status

    Secondary Outcome Measures

    1. Radiomics - MR image findings [4 weeks]

      Radiologic features

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age: 20-80 years

    • Patients diagnosed with mid-lower rectal cancer and expected to receive chemoradiotherapy before surgery

    Exclusion Criteria:

    • Patients with distal metastases confirmed at diagnosis

    • Patients with other bowel diseases such as IBD, ischemic colitis and TB colitis in addition to colorectal cancer

    • If patients do not agree with this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Cancer Center Goyang-si Gyeonggi-do Korea, Republic of 410-769

    Sponsors and Collaborators

    • National Cancer Center, Korea

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dae Kyung Sohn, Principal Investigator, National Cancer Center, Korea
    ClinicalTrials.gov Identifier:
    NCT04287400
    Other Study ID Numbers:
    • 2018-0428-0001
    First Posted:
    Feb 27, 2020
    Last Update Posted:
    Sep 5, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Rectal Neoplasms

    Study Results

    No Results Posted as of Sep 5, 2021