Significance of Benign Lymph Node Enlargement in Colorectal Cancer

Colorectal Neoplasms Malignant Clinical Trial

Official title:

Significance of Benign Lymph Node Enlargement in Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06410729
• Other study ID #: IRB00006761-M2020123
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2023
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this observational study was to investigate the clinical significance of benign mesenteric lymph node （BLNE） enlargement in patients with colorectal cancer. The main questions it aims to answer are:

Do patients with benign mesenteric lymph node enlargement have a better prognosis? What are the clinical characteristics of benign mesenteric lymph node enlargement? As part of routine medical care for colorectal cancer, we will follow up with all participants over the course of the study.

Description:

From January 2015 to June 2023, 2,270 patients with colorectal cancer received surgical treatment at Peking University Third Hospital. The clinical data of these patients were recorded retrospectively and the eligible patients were divided into two groups. According to the 9th edition of the TNM staging System published by the AJCC, the BLNE group included the mesenteric BLNE group, while the non-benign lymph node enlargement (NBLNE) group was the control group. Inclusion criteria were :1) No regional lymph node metastasis or distant metastasis; 2) Stage I and II patients with AJCC staging system; 3) Radical CRC resection reached R0 status, no positive lymph nodes; Colonoscopy confirmed a single malignant lesion. Exclusion criteria :1) emergency surgery or preoperative complications such as intestinal obstruction and perforation; 2) Positron emission tomography (PET-CT) suspected distant metastasis; 3) Preoperative neoadjuvant therapy; 4) Hereditary colorectal cancer such as familial adenomatous polyposis; Microsatellite instability (MSI) was confirmed by pathology. In early colorectal cancer, MSI-H status is associated with a favorable prognosis and enhanced anti-tumor immune response. Therefore, we excluded these patients to avoid their influence on prognosis. 6) Lack of imaging data; 7) Loss of follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2270
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• no regional lymph node metastasis or distant metastasis;

• stage I and II patients in the AJCC staging system;

• radical CRC resection achieving R0 status with no positive lymph nodes;

• a single malignant lesion confirmed via colonoscopy

Exclusion Criteria:

• underwent emergency surgery or had preoperative complications such as intestinal obstruction or perforation;

• had suspected distant metastasis on positron emission tomography (PET-CT);

• received preoperative neoadjuvant therapy;

• had hereditary CRC such as familial adenomatous polyposis;

• had microsatellite instability (MSI) confirmed by pathology.

• lacked imaging data;

• were lost to follow-up.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Colorectal Neoplasms Malignant
• Lymphadenopathy
• Neoplasms

Intervention

Other:
• Observational study, no intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival of participants	From the time participants started undergoing radical surgery until their tumors returned or they died from tumor causes. The unit is month.	The time from the participants' first postoperative day to their last follow-up.
Secondary	Overall survival of the participants	The time from the time participants began undergoing radical surgery until they died from any cause. Unit is month.	The time from the participants' first postoperative day to their last follow-up.