Colon CancerNCT06798857
Exploration of the Relationship Between Mismatch Repair Status of Colorectal Cancer and Lymph Node Metastasis Patterns and Pathological High-risk Factors
An observational study of Colon Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial summary
This study analyzed the differences in clinical baseline features and survival outcomes between pMMR and dMMR patients. The aim is to evaluate the impact of MMR status on overall survival and disease-free survival of colorectal patients, and to explore the population exempt from extended resection, so as to provide… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Colon Cancer
- How many people
- 1,471 participants
- Where
- No sites listed yet
- Study dates
- 14 Apr 2009to 9 Sep 2024
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study subjects were colon cancer patients who received radical surgical treatment at the Sixth Affiliated Hospital of Sun Yat-Sen University from January 2010 to December 2021. Patients must not have received neoadjuvant chemoradiotherapy and have a clear MMR status and necessary clinical and pathological information as well as follow-up prognostic information
Who may be able to join
- The preoperative diagnosis was primary colon adenocarcinoma;
- Undergoing radical surgical treatment;
- Postoperative immunohistochemistry to determine MMR status;
- Having complete key clinical and follow-up data.
Who cannot join
- Previous history of malignant tumors
- Concurrent distant metastasis
- Receiving preoperative neoadjuvant therapy.
About this study
This study analyzed the differences in clinical baseline features and survival outcomes between pMMR and dMMR patients. The aim is to evaluate the impact of MMR status on overall survival and disease-free survival of colorectal patients, and to explore the population exempt from extended resection, so as to provide evidence-based medical evidence for the relationship between MMR status, lymph node metastasis pattern and clinicopathological risk factors in colon cancer patients.
Read the detailed description
In recent years, colorectal cancer has become one of the most common cancers worldwide, and its prevalence and mortality are among the top three malignant tumors . Mismatch repair protein is considered to be one of the risk factors affecting the development of colorectal cancer, including MSH2, MSH6, MLH1, PMS2 and so on. However, their exact relationship to lymph node metastasis in patients with colorectal cancer is unclear. Studies have found that loss of expression of mismatch repair protein and positive expression of Her-2 are associated with lymph node metastasis in patients with colorectal cancer. On the other hand, MSI-H/dMMR colorectal cancer patients have a similar set of pathological features , such as the right half colon is more common, and lymph node or distant organ metastasis is less, but the relationship between the loss of mismatch repair status and skipping lymph node metastasis and other factors such as cancer nodules, nerve tract infiltration, and vascular cancer embolus has been ignored.
Right hemicolectomy combined with regional lymph node dissection is the standard operation for right hemicolectomy.However, there is no consensus on the scope of dissection, and different guidelines put forward different recommendations. For example, complete mesocolic excision (CME) combined with central vessel ligation (CVL) is recommended in Europe and the United States, while D3 surgery proposed by Japan has a large surgical risk. The surgical practice in China is consistent in principle with CME, but the scope of lymph node dissection tends to follow the Japanese D2/D3 scope of dissection, resulting in the lack of uniform standard.
Some studies have shown that expanding the scope of lymph node dissection can reduce the risk of local recurrence and distant metastasis, but this advantage is more significant in stage I to II patients, and there is no statistical difference in stage III colon cancer. At the same time, some studies have questioned the necessity of D3 dissection, arguing that the central group of lymph node metastasis is not significant, so D3 dissection is an overtreatment.
Therefore, the relationship between MMR status, lymph node metastasis pattern and clinicopathological risk factors in colon cancer patients needs to be further studied. Such research helps to stratify the management of patients at different risks and develop the most effective lymphatic dissection program for them, so as to provide individual and most appropriate treatment for each patient, in order to achieve the best treatment outcome and prognosis.
- Conditions
- Colon Cancer
- Medical subject headings
- Colonic Neoplasms
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 |
|---|---|---|
| pMMR group | Pathological immunohistochemical results suggested pMMR | |
| dMMR group | Pathological immunohistochemical results suggested dMMR |
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start14 Apr 2009
- Primary completion7 Sep 2021
- Study completion9 Sep 2024
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 Sixth Affiliated Hospital, Sun Yat-sen UniversityThe 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
- Retrospective
- Enrolment
- 1,471 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal 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
- NCT06798857
- Sponsor's protocol ID
- 2024ZSLYEC-289
- Status last verified
- Nov 2025
- First submitted
- 23 Jan 2025
- Last updated
- 2 Dec 2025
- 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 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Relationship Between Mismatch Repair Status of Colorectal Cancer and Lymph Node Metastasis Patterns and Pathological High-risk Factors
- ClinicalTrials.gov ID
- NCT06798857
- Acronym / sponsor ID
- 2024ZSLYEC-289
- Conditions
- Colon Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,471 participants (actual)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 14 Apr 2009 (actual)
- Primary completion
- 7 Sep 2021 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 29 Jan 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.
This study analyzed the differences in clinical baseline features and survival outcomes between pMMR and dMMR patients. The aim is to evaluate the impact of MMR status on overall survival and disease-free survival of colorectal patients, and to explore the population exempt from extended resection, so as to provide evidence-based medical evidence for the relationship between MMR status, lymph node metastasis pattern and clinicopathological risk factors in colon cancer patients.
Detailed description
In recent years, colorectal cancer has become one of the most common cancers worldwide, and its prevalence and mortality are among the top three malignant tumors . Mismatch repair protein is considered to be one of the risk factors affecting the development of colorectal cancer, including MSH2, MSH6, MLH1, PMS2 and so on. However, their exact relationship to lymph node metastasis in patients with colorectal cancer is unclear. Studies have found that loss of expression of mismatch repair protein and positive expression of Her-2 are associated with lymph node metastasis in patients with colorectal cancer. On the other hand, MSI-H/dMMR colorectal cancer patients have a similar set of pathological features , such as the right half colon is more common, and lymph node or distant organ metastasis is less, but the relationship between the loss of mismatch repair status and skipping lymph node metastasis and other factors such as cancer nodules, nerve tract infiltration, and vascular cancer embolus has been ignored.
Right hemicolectomy combined with regional lymph node dissection is the standard operation for right hemicolectomy.However, there is no consensus on the scope of dissection, and different guidelines put forward different recommendations. For example, complete mesocolic excision (CME) combined with central vessel ligation (CVL) is recommended in Europe and the United States, while D3 surgery proposed by Japan has a large surgical risk. The surgical practice in China is consistent in principle with CME, but the scope of lymph node dissection tends to follow the Japanese D2/D3 scope of dissection, resulting in the lack of uniform standard.
Some studies have shown that expanding the scope of lymph node dissection can reduce the risk of local recurrence and distant metastasis, but this advantage is more significant in stage I to II patients, and there is no statistical difference in stage III colon cancer. At the same time, some studies have questioned the necessity of D3 dissection, arguing that the central group of lymph node metastasis is not significant, so D3 dissection is an overtreatment.
Therefore, the relationship between MMR status, lymph node metastasis pattern and clinicopathological risk factors in colon cancer patients needs to be further studied. Such research helps to stratify the management of patients at different risks and develop the most effective lymphatic dissection program for them, so as to provide individual and most appropriate treatment for each patient, in order to achieve the best treatment outcome and prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pMMR group | – | –Pathological immunohistochemical results suggested pMMR |
| dMMR group | – | –Pathological immunohistochemical results suggested dMMR |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study subjects were colon cancer patients who received radical surgical treatment at the Sixth Affiliated Hospital of Sun Yat-Sen University from January 2010 to December 2021. Patients must not have received neoadjuvant chemoradiotherapy and have a clear MMR status and necessary clinical and pathological information as well as follow-up prognostic information
Key inclusion criteria (4 listed)
- The preoperative diagnosis was primary colon adenocarcinoma;
- Undergoing radical surgical treatment;
- Postoperative immunohistochemistry to determine MMR status;
- Having complete key clinical and follow-up data.
Key exclusion criteria (3 listed)
- Previous history of malignant tumors
- Concurrent distant metastasis
- Receiving preoperative neoadjuvant therapy.
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
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 Dec 2025.
- 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, run by Sixth Affiliated Hospital, Sun Yat-sen University.
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 4 inclusion and 3 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 Dec 2025. 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). 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 Dec 2025.