Colon CancerDIAMONDNCT07306390
Distribution and Analysis of Metastatic Lymph Nodes in Colorectal Cancer Patients (DIAMOND)
An observational study of Colon Cancer and Rectal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Cancer, Rectal Cancer
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 31 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Haizeng Zhang, Doctorate, +8613511003686, haizengzhang@163.com
About this study
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
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Colorectal Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Colorectal Cancer Patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The spatial distribution of metastatic lymph nodes
Measured: From enrollment to 14 days after surgery (at the completion of postoperative pathological examination)
Secondary outcomes (2)
Disease-free survival
Measured: 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
Measured: From date of surgery until the date of death from any cause, whichever came first, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Shanxi Province Cancer Hospital, Zhengzhou University
- Responsible party
- Principal investigator, HAI ZENG ZHAGN, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Haizeng Zhang, Doctorate, Study chair, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306390
- Sponsor's protocol ID
- 25/631-5577
- Acronym
- DIAMOND
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The Institutional Review Board or Ethics Committee may restrict the scope of all individual participant data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distribution and Analysis of Metastatic Lymph Nodes in Colorectal Cancer Patients (DIAMOND)
- ClinicalTrials.gov ID
- NCT07306390
- Acronym / sponsor ID
- DIAMOND / 25/631-5577
- Conditions
- Colon Cancer, Rectal Cancer
- Keywords
- Colorectal Cancer, Lymph Node Metastasis, Spatial Distribution
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Shanxi Province Cancer Hospital, Zhengzhou University
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal Cancer Patients | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The spatial distribution of metastatic lymph nodes
Time frame: From enrollment to 14 days after surgery (at the completion of postoperative pathological examination)
2 secondary outcomes
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
Overall survival
Time frame: From date of surgery until the date of death from any cause, whichever came first, assessed up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Undecided. The Institutional Review Board or Ethics Committee may restrict the scope of all individual participant data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Haizeng Zhang, Doctorate study chair
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Rectal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haizeng Zhang, Doctorate (+8613511003686, haizengzhang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The spatial distribution of metastatic lymph nodes (time frame: From enrollment to 14 days after surgery (at the completion of postoperative pathological examination)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.