Distribution and Analysis of Metastatic Lymph Nodes in Co... | NCT07306390

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

NCT07306390

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Status

Not yet recruiting

Last Update Posted

Jun 9, 2026Actual

Enrollment

1,200Estimated

Phase

Not provided

Conditions

Colon Cancer
Rectal Cancer

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2026Estimated

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Jan 31, 2028Estimated

First Submitted Date

Nov 25, 2025

First Submission Date that Met QC Criteria

Dec 13, 2025

First Posted Date

Dec 29, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2026

Last Update Posted Date

Jun 9, 2026Actual

Name	Class
China-Japan Friendship Hospital	OTHER
Shanxi Province Cancer Hospital	OTHER
Zhengzhou University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Estimated

Label	Type	Description	Intervention Names
Colorectal Cancer Patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Haizeng Zhang, Doctorate	Contact	+8613511003686		haizengzhang@163.com

Overall Officials

Name	Affiliation	Role
Haizeng Zhang, Doctorate	National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences		Beijing		100021	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms
D012004	Rectal Neoplasms
D015179	Colorectal Neoplasms
D008207	Lymphatic Metastasis

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided