Skip to main content
OpenTrials
Completed

NCT Number: NCT06798857

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

In recent years, colorectal cancer has become one of the most common cancers worldwide, and its prevalence and mortality are among the top three malignant tumors . Mismatch repair protein is considered to be one of the risk factors affecting the development of colorectal cancer, including MSH2, MSH6, MLH1, PMS2 and so on. However, their exact relationship to lymph node metastasis in patients with colorectal cancer is unclear. Studies have found that loss of expression of mismatch repair protein and positive expression of Her-2 are associated with lymph node metastasis in patients with colorectal cancer. On the other hand, MSI-H/dMMR colorectal cancer patients have a similar set of pathological features , such as the right half colon is more common, and lymph node or distant organ metastasis is less, but the relationship between the loss of mismatch repair status and skipping lymph node metastasis and other factors such as cancer nodules, nerve tract infiltration, and vascular cancer embolus has been ignored.

Right hemicolectomy combined with regional lymph node dissection is the standard operation for right hemicolectomy.However, there is no consensus on the scope of dissection, and different guidelines put forward different recommendations. For example, complete mesocolic excision (CME) combined with central vessel ligation (CVL) is recommended in Europe and the United States, while D3 surgery proposed by Japan has a large surgical risk. The surgical practice in China is consistent in principle with CME, but the scope of lymph node dissection tends to follow the Japanese D2/D3 scope of dissection, resulting in the lack of uniform standard.

Some studies have shown that expanding the scope of lymph node dissection can reduce the risk of local recurrence and distant metastasis, but this advantage is more significant in stage I to II patients, and there is no statistical difference in stage III colon cancer. At the same time, some studies have questioned the necessity of D3 dissection, arguing that the central group of lymph node metastasis is not significant, so D3 dissection is an overtreatment.

Therefore, the relationship between MMR status, lymph node metastasis pattern and clinicopathological risk factors in colon cancer patients needs to be further studied. Such research helps to stratify the management of patients at different risks and develop the most effective lymphatic dissection program for them, so as to provide individual and most appropriate treatment for each patient, in order to achieve the best treatment outcome and prognosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. DFS

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

    Disease Free Survival

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Important dates

Study start
2009
Primary completion
2021
Study completion
2024
First posted
Jan 29, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.