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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06130644
• Other study ID #: PRSYM202311
• Status: Completed
• Start date: January 1, 2003
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1451
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Lymphatic Metastasis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MSI status	(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.	through study completion, an average of 1 year
Secondary	Somatic Mutation Distribution	targeted NGS	through study completion, an average of 1 year
Secondary	Tumor Mutation Burden (TMB)	targeted NGS	through study completion, an average of 1 year