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NCT Number: NCT07306390

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Beijing, 100021, China

Location contact

Haizeng Zhang, Doctorate

CONTACT

[email protected]

+8613511003686

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. The spatial distribution of metastatic lymph nodes

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

Secondary outcomes

  1. Disease-free survival

    Time frame: 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

  2. Overall survival

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

Study contacts

Contact information is provided by the study sponsor or research team.

Haizeng Zhang, Doctorate

CONTACT

[email protected]

+8613511003686

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Collaborators

  • China-Japan Friendship Hospital
  • Shanxi Province Cancer Hospital
  • Zhengzhou University

Registry information

Acronym: DIAMOND

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Dec 29, 2025
Registry last updated
Jun 9, 2026

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.

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