Significance of Benign Lymph Node Enlargement in Colorectal Cancer

NCT06410729 | Completed

• 1 other identifier: IRB00006761-M2020123
• Study Type: observational
• Target: 2,270
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Colorectal Neoplasms Malignant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall survival of the participants

  The time from the participants' first postoperative day to their last follow-up.

Study Arms (3)

Benign mesenteric lymph node enlargement (BLNE)

Lymph nodes with a diameter \> 8 mm on preoperative imaging without metastasis on postoperative pathology were termed benign mesenteric lymph node enlargement.

Other: Observational study, no intervention

Non-benign mesenteric lymph node enlargement (NBLNE)

Lymph nodes with a diameter \< 8 mm on preoperative imaging without metastasis on postoperative pathology were termed non-benign mesenteric lymph node enlargement.

Other: Observational study, no intervention

Metastatic mesenteric lymph node enlargement (MLNE)

Lymph nodes with a diameter \> 8 mm on preoperative imaging with metastasis on postoperative pathology were termed metastatic mesenteric lymph node enlargement .

Other: Observational study, no intervention

Interventions

Observational study, no intervention OTHER

Benign mesenteric lymph node enlargement (BLNE); Metastatic mesenteric lymph node enlargement (MLNE); Non-benign mesenteric lymph node enlargement (NBLNE)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone radical colorectal cancer surgery

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Observation

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Junwei Wang, M.D.

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 13, 2024
• Study Start: January 1, 2015
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: May 14, 2024

Record last verified: 2023-06