Gastric / Gastroesophageal Junction AdenocarcinomaNCT07625735
MMR Status Modulates the Predictive Value of Lymphatic Invasion for Lymph Node Metastasis in Gastrointestinal Cancers
An observational study of Gastric / Gastroesophageal Junction Adenocarcinoma and Mismatch Repair Deficient or MSI-High Solid Tumors, run by Shanghai Zhongshan Hospital.
Trial summary
Lymph node metastasis (LNM) is a key factor influencing treatment decisions and prognosis in patients with gastric cancer. Lymphatic invasion (LI) is an important pathological predictor of LNM and a core component of the eCURA risk scoring system after endoscopic submucosal dissection (ESD) for early gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Gastric / Gastroesophageal Junction Adenocarcinoma, Mismatch Repair Deficient or MSI-High Solid Tumors, Lymph Node Metastasis
- What is being tested?
- Mismatch repair (MMR) status and Lymphatic invasion status
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 31 Jul 2027
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This multicenter, retrospective observational cohort study will include patients with pathologically confirmed gastric or gastroesophageal junction adenocarcinoma or colorectal adenocarcinoma treated at Zhongshan Hospital, Fudan University, and five participating centers in China. Patients treated between January 2018 and April 2026 will be retrospectively identified from electronic medical records, surgical records, and pathology databases. The study population comprises three cohorts: 1. Gastric cancer upfront surgery cohort: Patients who underwent upfront radical gastrectomy. 2. Gastric cancer ESD cohort: Patients who underwent ESD with available pathological information for eCURA risk assessment. 3. Colorectal cancer surgery cohort: Patients who underwent upfront radical surgery.
Who may be able to join
- Gastric cancer upfront surgery cohort
- Patients who underwent radical surgery for gastric cancer.
- Patients who did not receive neoadjuvant chemotherapy, radiotherapy, immunotherapy, or other antitumor treatments that may affect the pathological assessment of the primary tumor or lymph node metastasis before surgery.
- Patients with pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma after surgery, including Siewert type II and III tumors only.
- Patients with definite pathological assessment of lymphatic invasion and regional lymph node status.
- Patients with available and definite MMR status.
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- Gastric cancer ESD cohort
- Patients who underwent ESD for gastric cancer.
- Patients with pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma after ESD, including Siewert type II and III tumors only.
- Patients with complete post-ESD pathological information, including histological type, depth of invasion, tumor size, ulcerative findings, lymphatic invasion status, venous invasion status, horizontal margin status, and vertical margin status.
- Patients with available and definite MMR status.
- Colorectal cancer upfront surgery cohort
- Patients who underwent radical surgery for colorectal cancer.
- Patients who did not receive neoadjuvant chemotherapy, radiotherapy, immunotherapy, or other anti-tumor treatments that may affect the pathological assessment of the primary tumor or lymph node metastasis before surgery.
- Patients with pathologically confirmed colorectal adenocarcinoma.
- Patients with definite pathological assessment of lymphatic invasion and regional lymph node status.
- Patients with available and definite MMR status.
Who cannot join
- Gastric cancer upfront surgery cohort
- Patients with other pathological types, such as gastric squamous cell carcinoma or neuroendocrine carcinoma.
- Patients who received neoadjuvant treatment before surgery, including chemotherapy, radiotherapy, immunotherapy, targeted therapy, or other systemic antitumor treatments.
- Patients with missing postoperative pathological information, resulting in inability to determine lymphatic invasion or regional lymph node metastasis status.
- Patients with missing or indeterminate MMR status.
- Patients with concurrent malignancies that may interfere with the determination of the origin of lymph node metastasis.
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- Gastric cancer ESD cohort
- Patients with other pathological types, such as gastric squamous cell carcinoma or neuroendocrine carcinoma.
- Patients with missing post-ESD pathological information that precludes eCURA classification, eCURA risk score calculation, or assessment of lymphatic invasion status.
- Patients with missing or indeterminate MMR status.
- Colorectal cancer upfront surgery cohort
- Patients with other pathological types, such as neuroendocrine carcinoma.
- Patients who received neoadjuvant treatment before surgery, including chemotherapy, radiotherapy, immunotherapy, targeted therapy, or other systemic anti-tumor treatments.
- Patients with missing postoperative pathological information, resulting in inability to determine lymphatic invasion or regional lymph node metastasis status.
- Patients with missing or indeterminate MMR status.
- Patients with concurrent malignancies that may interfere with the determination of the origin of lymph node metastasis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Lymph node metastasis (LNM) is a key factor influencing treatment decisions and prognosis in patients with gastric cancer. Lymphatic invasion (LI) is an important pathological predictor of LNM and a core component of the eCURA risk scoring system after endoscopic submucosal dissection (ESD) for early gastric cancer. However, whether LI has the same predictive value for LNM across different mismatch repair (MMR) statuses remains unclear. Compared with proficient mismatch repair (pMMR) gastric cancer, deficient mismatch repair (dMMR) gastric cancer has distinct molecular pathological features and an immune-enriched tumor microenvironment. In early gastric cancer, if LI is associated with a lower LNM risk in dMMR tumors than in pMMR tumors, existing LI-based eCURA risk assessment may overestimate LNM risk in patients with dMMR early gastric cancer and consequently affect decisions regarding additional surgery after ESD.
Therefore, this study aims to systematically evaluate the association between MMR status, LI, and LNM using multi-center cohorts of patients with GC who underwent upfront gastrectomy or additional gastrectomy following ESD, and to explore the potential clinical value of incorporating MMR status into eCURA-based risk stratification for early GC. Furthermore, an independent colorectal cancer surgical cohort will be included to investigate whether these associations are consistent across different gastrointestinal malignancies.
- Conditions
- Gastric / Gastroesophageal Junction Adenocarcinoma, Mismatch Repair Deficient or MSI-High Solid Tumors, Lymph Node Metastasis, Lymphatic Invasion, Gastrointestinal Cancer
- Being tested
- Mismatch repair (MMR) status, Lymphatic invasion status
- Medical subject headings
- Turcot syndrome, Lymphatic Metastasis, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mismatch repair (MMR) statusOther
Mismatch repair (MMR) status was assessed as part of routine pathological evaluation. Patients were classified as deficient mismatch repair (dMMR) or proficient mismatch repair (pMMR) according to immunohistochemical expression of MLH1, PMS2, MSH2, and MSH6.
Lymphatic invasion statusOther
Lymphatic invasion status was determined from routine pathological reports and classified as LI-positive or LI-negative.
| Study group | Role | What they receive |
|---|---|---|
| dMMR gastric cancer | Patients with gastric cancer classified as deficient mismatch repair (dMMR) based on routine pathological testing. Receives: Other: Mismatch repair (MMR) status; Other: Lymphatic invasion status | |
| pMMR gastric cancer | Patients with gastric cancer classified as proficient mismatch repair (pMMR) based on routine pathological assessment. Receives: Other: Mismatch repair (MMR) status; Other: Lymphatic invasion status | |
| dMMR colorectal cancer | Patients with pathologically confirmed colorectal adenocarcinoma classified as deficient mismatch repair (dMMR) based on routine immunohistochemical assessment of MLH1, PMS2, MSH2, and MSH6. Receives: Other: Mismatch repair (MMR) status; Other: Lymphatic invasion status | |
| pMMR colorectal cancer | Patients with pathologically confirmed colorectal adenocarcinoma classified as proficient mismatch repair (pMMR) based on routine immunohistochemical assessment of MLH1, PMS2, MSH2, and MSH6. Receives: Other: Mismatch repair (MMR) status; Other: Lymphatic invasion status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymph Node Metastasis Rate Among LI-Positive Gastric Cancer Patients
LI positivity is defined as lymphatic invasion explicitly documented in the pathological report or tumor emboli within lymphatic vessels confirmed by D2-40 immunohistochemistry. LNM is defined as regional lymph node metastasis confirmed by postoperative pathological examination. The LNM rate among LI-positive patients is calculated as the number of patients with LNM divided by the total number of LI-positive patients in the corresponding group.
Measured: At postoperative pathological assessment, approximately 14 days after upfront surgery
Secondary outcomes (4)
LI Positivity Rate According to MMR Status
This outcome evaluates differences in LI positivity rate between patients with dMMR and pMMR gastric cancer. LI positivity rate is calculated as the number of LI-positive patients divided by the total number of patients in each MMR group.
Measured: At postoperative pathological assessment, approximately 14 days after upfront surgery
Overall LNM Rate According to MMR Status
This outcome evaluates differences in overall LNM rate between patients with dMMR and pMMR gastric cancer. Overall LNM rate is calculated as the number of patients with pathologically confirmed LNM divided by the total number of patients in each MMR group.
Measured: At postoperative pathological assessment, approximately 14 days after upfront surgery
eCURA Risk Stratification and LI Contribution in the Gastric Cancer ESD Cohort
This outcome evaluates differences in eCURA classification, eCURA risk score distribution, and the contribution of LI to the risk score between dMMR and pMMR patients in the gastric cancer ESD cohort. LI contribution is assessed based on its role in eCURA-C2 classification and/or its component score contribution within the eCURA risk scoring system.
Measured: At pathological assessment of the ESD specimen, approximately 14 days after ESD
LNM Rate Among LI-Positive Patients in the cohort undergoing additional gastrectomy after ESD
This outcome evaluates differences in LNM risk between LI-positive dMMR and pMMR patients with early gastric cancer who underwent additional surgery after ESD. LNM is defined as regional lymph node metastasis confirmed by pathological examination of the additional surgical specimen. LNM rate is calculated as the number of patients with LNM divided by the total number of LI-positive patients in each MMR group.
Measured: At postoperative pathological assessment, approximately 14 days after additional surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric / Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625735
- Sponsor's protocol ID
- B2026-354
- Status last verified
- Oct 2026
- First submitted
- 19 May 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to patient privacy concerns and institutional data protection regulations. De-identified aggregate data may be made available from the corresponding author upon reasonable request and with appropriate institutional approval.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MMR Status Modulates the Predictive Value of Lymphatic Invasion for Lymph Node Metastasis in Gastrointestinal Cancers
- ClinicalTrials.gov ID
- NCT07625735
- Acronym / sponsor ID
- B2026-354
- Conditions
- Gastric / Gastroesophageal Junction Adenocarcinoma, Mismatch Repair Deficient or MSI-High Solid Tumors, Lymph Node Metastasis, Lymphatic Invasion, Gastrointestinal Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 4 Jun 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.
Lymph node metastasis (LNM) is a key factor influencing treatment decisions and prognosis in patients with gastric cancer. Lymphatic invasion (LI) is an important pathological predictor of LNM and a core component of the eCURA risk scoring system after endoscopic submucosal dissection (ESD) for early gastric cancer. However, whether LI has the same predictive value for LNM across different mismatch repair (MMR) statuses remains unclear. Compared with proficient mismatch repair (pMMR) gastric cancer, deficient mismatch repair (dMMR) gastric cancer has distinct molecular pathological features and an immune-enriched tumor microenvironment. In early gastric cancer, if LI is associated with a lower LNM risk in dMMR tumors than in pMMR tumors, existing LI-based eCURA risk assessment may overestimate LNM risk in patients with dMMR early gastric cancer and consequently affect decisions regarding additional surgery after ESD.
Therefore, this study aims to systematically evaluate the association between MMR status, LI, and LNM using multi-center cohorts of patients with GC who underwent upfront gastrectomy or additional gastrectomy following ESD, and to explore the potential clinical value of incorporating MMR status into eCURA-based risk stratification for early GC. Furthermore, an independent colorectal cancer surgical cohort will be included to investigate whether these associations are consistent across different gastrointestinal malignancies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| dMMR gastric cancer | – | Other: Mismatch repair (MMR) status, Other: Lymphatic invasion statusPatients with gastric cancer classified as deficient mismatch repair (dMMR) based on routine pathological testing. |
| pMMR gastric cancer | – | Other: Mismatch repair (MMR) status, Other: Lymphatic invasion statusPatients with gastric cancer classified as proficient mismatch repair (pMMR) based on routine pathological assessment. |
| dMMR colorectal cancer | – | Other: Mismatch repair (MMR) status, Other: Lymphatic invasion statusPatients with pathologically confirmed colorectal adenocarcinoma classified as deficient mismatch repair (dMMR) based on routine immunohistochemical assessment of MLH1, PMS2, MSH2, and MSH6. |
| pMMR colorectal cancer | – | Other: Mismatch repair (MMR) status, Other: Lymphatic invasion statusPatients with pathologically confirmed colorectal adenocarcinoma classified as proficient mismatch repair (pMMR) based on routine immunohistochemical assessment of MLH1, PMS2, MSH2, and MSH6. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This multicenter, retrospective observational cohort study will include patients with pathologically confirmed gastric or gastroesophageal junction adenocarcinoma or colorectal adenocarcinoma treated at Zhongshan Hospital, Fudan University, and five participating centers in China. Patients treated between January 2018 and April 2026 will be retrospectively identified from electronic medical records, surgical records, and pathology databases. The study population comprises three cohorts: 1. Gastric cancer upfront surgery cohort: Patients who underwent upfront radical gastrectomy. 2. Gastric cancer ESD cohort: Patients who underwent ESD with available pathological information for eCURA risk assessment. 3. Colorectal cancer surgery cohort: Patients who underwent upfront radical surgery.
Key inclusion criteria (17 listed)
- Gastric cancer upfront surgery cohort
- Gastric cancer ESD cohort
- Colorectal cancer upfront surgery cohort
Key exclusion criteria (16 listed)
- Gastric cancer upfront surgery cohort
- Gastric cancer ESD cohort
- Colorectal cancer upfront surgery cohort
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mismatch repair (MMR) statusMismatch repair (MMR) status was assessed as part of routine pathological evaluation. Patients were classified as deficient mismatch repair (dMMR) or proficient mismatch repair (pMMR) according to immunohistochemical expression of MLH1, PMS2, MSH2, and MSH6. | Other | dMMR colorectal cancer, dMMR gastric cancer, pMMR colorectal cancer, pMMR gastric cancer |
| Lymphatic invasion statusLymphatic invasion status was determined from routine pathological reports and classified as LI-positive or LI-negative. | Other | dMMR colorectal cancer, dMMR gastric cancer, pMMR colorectal cancer, pMMR gastric cancer |
Primary outcome
Lymph Node Metastasis Rate Among LI-Positive Gastric Cancer Patients
Time frame: At postoperative pathological assessment, approximately 14 days after upfront surgery
LI positivity is defined as lymphatic invasion explicitly documented in the pathological report or tumor emboli within lymphatic vessels confirmed by D2-40 immunohistochemistry. LNM is defined as regional lymph node metastasis confirmed by postoperative pathological examination. The LNM rate among LI-positive patients is calculated as the number of patients with LNM divided by the total number of LI-positive patients in the corresponding group.
4 secondary outcomes
LI Positivity Rate According to MMR Status
Time frame: At postoperative pathological assessment, approximately 14 days after upfront surgery
Overall LNM Rate According to MMR Status
Time frame: At postoperative pathological assessment, approximately 14 days after upfront surgery
eCURA Risk Stratification and LI Contribution in the Gastric Cancer ESD Cohort
Time frame: At pathological assessment of the ESD specimen, approximately 14 days after ESD
LNM Rate Among LI-Positive Patients in the cohort undergoing additional gastrectomy after ESD
Time frame: At postoperative pathological assessment, approximately 14 days after additional surgery
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 27 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to patient privacy concerns and institutional data protection regulations. De-identified aggregate data may be made available from the corresponding author upon reasonable request and with appropriate institutional approval.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric / Gastroesophageal Junction Adenocarcinoma and Mismatch Repair Deficient or MSI-High Solid Tumors, run by Shanghai Zhongshan Hospital.
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 17 inclusion and 16 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 27 Oct 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?
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 Zhaoqing Tang (86-021-64041990, tang.zhaoqing@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymph Node Metastasis Rate Among LI-Positive Gastric Cancer Patients (time frame: At postoperative pathological assessment, approximately 14 days after upfront surgery). 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 27 Oct 2026.