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

June 7, 2026 updated by: HAI ZENG ZHAGN, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100021
        • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Colorectal Cancer Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The spatial distribution of metastatic lymph nodes
Time Frame: From enrollment to 14 days after surgery (at the completion of postoperative pathological examination)
From enrollment to 14 days after surgery (at the completion of postoperative pathological examination)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

Shanxi Province Cancer Hospital
China-Japan Friendship Hospital
Zhengzhou University

Investigators

  • Study Chair: Haizeng Zhang, Doctorate, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

December 13, 2025

First Posted (Actual)

December 29, 2025

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 7, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25/631-5577

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The Institutional Review Board or Ethics Committee may restrict the scope of all individual participant data sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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