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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06130644

Enrollment

1451

Registered

2023-11-14

Start date

2003-01-01

Completion date

2022-12-31

Last updated

2023-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results