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Early Lymph Node Metastasis in T1/2 Stage Colorectal Cancer: Molecular and Clinical Insights

Sponsor
The First Affiliated Hospital with Nanjing Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT06130644
Collaborator
(none)
1,451
Enrollment
240
Actual Duration (Months)

Study Details

Study Description

Brief Summary

The prognostic implications of lymph node metastasis in colorectal cancer patients at an early stage, specifically T1/2 stage, are relatively unfavorable. Therefore, understanding the clinical and molecular traits relevant to metastasis in T1/2 stage are of substantial clinical importance.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patients were classified based on their lymph node staging, with an ancillary categorization into MSI-H and MSS subgroups. A comparative mutational study was performed among these groups, incorporating risk stratification and Receiver Operating Characteristic curve analysis, with the aim of discerning the predictability of clinical features integrated with molecular characteristics for early metastasis in T1/2 stage colorectal cancer.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    1451 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Early Lymph Node Metastasis in T1/2 Stage Colorectal Cancer: Molecular and Clinical Insights
    Actual Study Start Date :
    Jan 1, 2003
    Actual Primary Completion Date :
    Dec 31, 2022
    Actual Study Completion Date :
    Dec 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with lymph node metastasis

    T1/2N+ patients
    Patients without lymph node metastasis

    T1/2N- patients

    Outcome Measures

    Primary Outcome Measures

    1. MSI status [through study completion, an average of 1 year]

      (I) MSI-High (MSI-H) if two or more mononucleotide markers in tumor tissue had size variations of ≥3bp compared to normal tissue; (II) MSI-Low (MSI-L) if a single mononucleotide marker in tumor tissue exhibited a size variation of ≥3bp compared to normal tissue; (III) Microsatellite Stable (MSS) if there were no size variations of ≥3bp in mononucleotide markers in tumor tissue compared to normal tissue.

    Secondary Outcome Measures

    1. Somatic Mutation Distribution [through study completion, an average of 1 year]

      targeted NGS

    2. Tumor Mutation Burden (TMB) [through study completion, an average of 1 year]

      targeted NGS

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Men and women aged 18-75 years old;

    • Clinical staged T2;

    • Histologically proven colon or rectal adenocarcinoma.

    Exclusion Criteria:

    • Patients over 80 years of age;

    • Recurrent colorectal cancer;

    • Multiple primary tumors;

    • Distant metastasis.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • The First Affiliated Hospital with Nanjing Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The First Affiliated Hospital with Nanjing Medical University
    ClinicalTrials.gov Identifier:
    NCT06130644
    Other Study ID Numbers:
    • PRSYM202311
    First Posted:
    Nov 14, 2023
    Last Update Posted:
    Nov 14, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Lymphatic Metastasis

    Study Results

    No Results Posted as of Nov 14, 2023