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

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT06130644
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

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 Timeline

• Study Start: 2003-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-11
• Study First Submitted: 2023-11-01
• Study First Submitted QC: 2023-11-08
• Last Update Submitted: 2023-11-08
• Study First Posted: 2023-11-14
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1451

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Somatic Mutation Distribution	through study completion, an average of 1 year	targeted NGS
Tumor Mutation Burden (TMB)	through study completion, an average of 1 year	targeted NGS