Colon CancerNCT07380464
A New Classification System for Lymph Nodes in Colon Cancer: The Prognostic Significance of the Anatomical Distribution of Metastatic Lymph Nodes and the Number of Tumor Deposits
An observational study of Colon Cancer and Tumor Deposits, run by Cai Zerong.
Trial summary
This study aims to investigate the prognostic significance of LNM distribution and establish a new classification system integrating both nodal quantity and anatomical location.The main question it aims to answer is: Does the new N staging based on lymph node metastasis patterns and cancer nodules provide a more… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colon Cancer, Tumor Deposits, Lymph Node Metastases
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 5 Mar 2010to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study enrolled a total of 1,500 participants between January 2010 and December 2022. Inclusion criteria were defined as follows: (1) a confirmed diagnosis of primary colon adenocarcinoma via auxiliary examination or pathology; (2) absence of distant metastasis (M0) verified by preoperative imaging or intraoperative findings; (3) initial radical colectomy; and (4) complete documentation of lymph node counts across three stations. Patients were excluded if they had received any form of neoadjuvant therapy (including chemotherapy, radiotherapy, immunotherapy, or targeted therapy) prior to surgery. Additionally, cases were excluded if intraoperative or postoperative pathology revealed non-malignant tumors (including carcinoma in Tis) or if patients presented with multiple primary cancers or concurrent malignancies in other sites.
Who may be able to join
- Definite diagnosis of primary colon adenocarcinoma via auxiliary examination or pathology.
- No distant metastasis (M0) confirmed by preoperative imaging or intraoperative findings.
- No prior neoadjuvant therapy (including chemotherapy, radiotherapy, immunotherapy, or targeted therapy).
- Underwent initial radical resection for colon cancer.
- Available data on lymph node counts for all three stations.
Who cannot join
- Intraoperative or postoperative pathology confirming non-malignant tumors (including carcinoma in Tis).
- Multiple primary cancers or concurrent malignancies in other sites.
About this study
This study aims to investigate the prognostic significance of LNM distribution and establish a new classification system integrating both nodal quantity and anatomical location.The main question it aims to answer is:
Does the new N staging based on lymph node metastasis patterns and cancer nodules provide a more accurate prediction of the prognosis of colon cancer patients compared to the AJCC N staging? The relevant clinical characteristics, treatment processes, postoperative pathological data and post-discharge prognosis information of the enrolled patients were collected through the follow-up offices and the medical record system. The data were analyzed. The main research endpoints were: overall survival (the time between the initial surgery and death or the last follow-up); disease-free survival (the time between the initial surgery and disease metastasis, recurrence or death).
- Conditions
- Colon Cancer, Tumor Deposits, Lymph Node Metastases, TNM Staging
- Keywords
- Colon Cancer, Lymph Node Metastases, N stage
- Medical subject headings
- Colonic Neoplasms, Extranodal Extension, 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 |
|---|---|---|
| No metastasis | Not described | |
| Non-skip metastasis without tumor deposits | Not described | |
| No metastasis or non-skip metastasis with tumor deposits，Skip metastasis without tumor deposits | Not described | |
| Skip metastasis with tumor deposits, All-station metastasis regardless of tumor deposits | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
Disease Free Survival
Measured: From the date of the initial surgery to death or disease recurrence or metastasis,assessed up to 120 months
OS
Overall Survival
Measured: From the date of the initial surgery to death, assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start5 Mar 2010
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
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.
- 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
- Retrospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cai Zerong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cai Zerong, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Zerong Cai, MD, Study director, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380464
- Sponsor's protocol ID
- 2025ZSLYEC-785
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Please contact us by Email.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Classification System for Lymph Nodes in Colon Cancer: The Prognostic Significance of the Anatomical Distribution of Metastatic Lymph Nodes and the Number of Tumor Deposits
- ClinicalTrials.gov ID
- NCT07380464
- Acronym / sponsor ID
- 2025ZSLYEC-785
- Conditions
- Colon Cancer, Tumor Deposits, Lymph Node Metastases, TNM Staging
- Keywords
- Colon Cancer, Lymph Node Metastases, N stage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Cai ZerongUniversity, hospital or other
- Study start
- 5 Mar 2010 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 2 Feb 2026 (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.
This study aims to investigate the prognostic significance of LNM distribution and establish a new classification system integrating both nodal quantity and anatomical location.The main question it aims to answer is:
Does the new N staging based on lymph node metastasis patterns and cancer nodules provide a more accurate prediction of the prognosis of colon cancer patients compared to the AJCC N staging? The relevant clinical characteristics, treatment processes, postoperative pathological data and post-discharge prognosis information of the enrolled patients were collected through the follow-up offices and the medical record system. The data were analyzed. The main research endpoints were: overall survival (the time between the initial surgery and death or the last follow-up); disease-free survival (the time between the initial surgery and disease metastasis, recurrence or death).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No metastasis | – | – |
| Non-skip metastasis without tumor deposits | – | – |
| No metastasis or non-skip metastasis with tumor deposits，Skip metastasis without tumor deposits | – | – |
| Skip metastasis with tumor deposits, All-station metastasis regardless of tumor deposits | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study enrolled a total of 1,500 participants between January 2010 and December 2022. Inclusion criteria were defined as follows: (1) a confirmed diagnosis of primary colon adenocarcinoma via auxiliary examination or pathology; (2) absence of distant metastasis (M0) verified by preoperative imaging or intraoperative findings; (3) initial radical colectomy; and (4) complete documentation of lymph node counts across three stations. Patients were excluded if they had received any form of neoadjuvant therapy (including chemotherapy, radiotherapy, immunotherapy, or targeted therapy) prior to surgery. Additionally, cases were excluded if intraoperative or postoperative pathology revealed non-malignant tumors (including carcinoma in Tis) or if patients presented with multiple primary cancers or concurrent malignancies in other sites.
Key inclusion criteria (5 listed)
- Definite diagnosis of primary colon adenocarcinoma via auxiliary examination or pathology.
- No distant metastasis (M0) confirmed by preoperative imaging or intraoperative findings.
- No prior neoadjuvant therapy (including chemotherapy, radiotherapy, immunotherapy, or targeted therapy).
- Underwent initial radical resection for colon cancer.
- Available data on lymph node counts for all three stations.
Key exclusion criteria (2 listed)
- Intraoperative or postoperative pathology confirming non-malignant tumors (including carcinoma in Tis).
- Multiple primary cancers or concurrent malignancies in other sites.
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
DFS
Time frame: From the date of the initial surgery to death or disease recurrence or metastasis,assessed up to 120 months
Disease Free Survival
OS
Time frame: From the date of the initial surgery to death, assessed up to 120 months
Overall Survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No. Please contact us by Email.
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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. This study is not recruiting at the moment.
Zerong Cai, MD study director
Sixth Affiliated Hospital, Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Tumor Deposits, run by Cai Zerong.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (time frame: From the date of the initial surgery to death or disease recurrence or metastasis,assessed up to 120 months). The study lists 2 primary outcomes in all. 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 2 Feb 2026.