Exploration of the Relationship Between Mismatch Repair Status of Colorectal Cancer and Lymph Node Metastasis Patterns and Pathological High-risk Factors

NCT06798857 | Completed

• 1 other identifier: 2024ZSLYEC-289
• Study Type: observational
• Target: 1,471
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study analyzed the differences in clinical baseline features and survival outcomes between pMMR and dMMR patients. The aim is to evaluate the impact of MMR status on overall survival and disease-free survival of colorectal patients, and to explore the population exempt from extended resection, so as to provide evidence-based medical evidence for the relationship between MMR status, lymph node metastasis pattern and clinicopathological risk factors in colon cancer patients.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

• DFS

  Disease Free Survival

  From the date of the initial surgery to death or disease recurrence or metastasis,assessed up to 120 months

Study Arms (2)

pMMR group

Pathological immunohistochemical results suggested pMMR

dMMR group

Pathological immunohistochemical results suggested dMMR

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study subjects were colon cancer patients who received radical surgical treatment at the Sixth Affiliated Hospital of Sun Yat-Sen University from January 2010 to December 2021. Patients must not have received neoadjuvant chemoradiotherapy and have a clear MMR status and necessary clinical and pathological information as well as follow-up prognostic information

You may qualify if:

• The preoperative diagnosis was primary colon adenocarcinoma;
• Undergoing radical surgical treatment;
• Postoperative immunohistochemistry to determine MMR status;
• Having complete key clinical and follow-up data.

You may not qualify if:

• Previous history of malignant tumors
• Concurrent distant metastasis
• Receiving preoperative neoadjuvant therapy.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

The pathological specimens before operation and the specimens after operation

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Zerong Cai, MD

  Sixth Affiliated Hospital, Sun Yat-sen University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: April 14, 2009
• Primary Completion: September 7, 2021
• Study Completion: September 9, 2024
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share