Distribution and Analysis of Metastatic Lymph Nodes in Colorectal Cancer Patients (DIAMOND)

NCT07306390 | Not Yet Recruiting

• 1 other identifier: 25/631-5577
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the spatial distribution and significance of metastatic lymph nodes in colorectal cancer patients. The main question it aims to answer is:

• What is the spatial distribution pattern of metastatic lymph nodes in patients with colorectal cancer?
• Can the spatial distribution pattern of metastatic lymph nodes in patients with colorectal cancer guide clinical practice? Participants should undergo regular follow-up examinations for at least 5 years after the surgery.

Conditions

Colon Cancer; Rectal Cancer

Keywords

Colorectal Cancer; Lymph Node Metastasis; Spatial Distribution

Outcome Measures

Primary Outcomes (1)

• The spatial distribution of metastatic lymph nodes

  From enrollment to 14 days after surgery (at the completion of postoperative pathological examination)

Secondary Outcomes (2)

• Disease-free survival

  From date of surgery until the date of first documented local recurrence, distant metastasis, or date of death from any cause, whichever came first, assessed up to 60 months

• Overall survival

  From date of surgery until the date of death from any cause, whichever came first, assessed up to 60 months

Study Arms (1)

Colorectal Cancer Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Colorectal cancer patients who undergo radical resection in the National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, China-Japan Friendship Hospital, Shanxi Cancer Hospital, and The Affiliated Cancer Hospital of Zhengzhou University \& Henan Cancer Hospital between December 2025 and December 2027.

You may qualify if:

• Aged between 18 and 80 years
• Pathologically confirmed adenocarcinoma of the colon or rectum
• Underwent radical resection for colorectal cancer with a D3 lymphadenectomy and lymph nodes were submitted for pathological examination according to standardized station-based and distance-based protocol
• No distant metastasis or distant metastasis within 6 months after surgery
• No history of other malignant tumors or severe systemic diseases
• No immune diseases or inflammatory bowel diseases
• Non-emergency surgery
• With complete clinicopathological and follow-up data

You may not qualify if:

• Pathologically confirmed benign tumors or non-adenocarcinoma malignancies
• Underwent local excision or palliative resection
• Regional lymph nodes were not dissected or submitted for pathological examination according to the unified station-based or distance-based protocol
• With distant metastasis or distant metastasis within 6 months after surgery
• Dual or multiple primary colorectal cancers or concurrent other malignant tumors
• Had a previous diagnosis of immune diseases or inflammatory bowel disease such as ulcerative colitis or Crohn's disease
• Underwent emergency surgery
• Had incomplete clinicopathological or follow-up data

Sponsors & Collaborators

• China-Japan Friendship Hospital: collaborator
• Shanxi Province Cancer Hospital: collaborator
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Zhengzhou University: collaborator

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Colorectal Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Haizeng Zhang, Doctorate

  National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Haizeng Zhang, Doctorate

CONTACT

+8613511003686; haizengzhang@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 29, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

CN (1)