Mixed-type Early Gastric CancerMTEGCNCT07096947
A Multifactor Prediction Model for Non-curative Outcomes in Mixed-type Early Gastric Cancer
An observational study of Mixed-type Early Gastric Cancer, run by The First Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
The goal of this dual-center study is to identify the most valuable predictive factors (MVPs) for non-curable mixed-type early gastric cancer (NC-MTEGC) and develop a nomogram scoring model to assist surgeons in formulating precise postoperative combined radiochemotherapy strategies in patients with mixed-type early… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Mixed-type Early Gastric Cancer
- How many people
- 421 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2017to 15 Jun 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: mixed-type early gastric cancer
Who may be able to join
- Mixed-type early gastric cancer (MTEGC);
- Receive a surgical procedure;
- Complete preoperative data.
Who cannot join
- Received neoadjuvant therapy;
- History of gastrectomy;
- Previous cancer or residual gastric cancer (GC);
- Distant metastasis at diagnosis;
- Incomplete preoperative data;
- Undifferentiated MTEGC components;
- Missing imaging data or refusal of follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital of Nanchang University
Nanchang, Jiangxi, 330006
About this study
Official title: A Multifactor Prediction Model for Non-curative Outcomes in Mixed-type Early Gastric Cancer: a Retrospective Cohort Study
The goal of this dual-center study is to identify the most valuable predictive factors (MVPs) for non-curable mixed-type early gastric cancer (NC-MTEGC) and develop a nomogram scoring model to assist surgeons in formulating precise postoperative combined radiochemotherapy strategies in patients with mixed-type early gastric cancer (MTEGC) who have undergone radical surgical resection. The main question it aims to answer is:
What are the most valuable predictive factors for NC-MTEGC, and can a nomogram scoring model developed based on these factors effectively assist in formulating precise postoperative combined radiochemotherapy strategies?
Patients with MTEGC who have undergone radical surgical resection (including 160 in the training group, 151 in the internal validation set from the First Affiliated Hospital of Nanchang University, and 110 in the external test cohort from the Second Affiliated Hospital of Nanchang University) will be included in the study. The Least Absolute Shrinkage and Selection Operator (LASSO) algorithm will be used to assess key predictive indicators, a nomogram prediction model will be developed based on logistic regression, and an NC-MTEGC risk score model will be constructed. Meanwhile, the model's discriminatory ability, calibration, and clinical utility will be comprehensively validated across the three cohorts, with follow-up for relevant conditions.
- Conditions
- Mixed-type Early Gastric Cancer
- Keywords
- Mixed-type Early Gastric Cancer, Non-curative Outcomes, Nomogram Model, Prognosis, Dual-center Retrospective Cohort
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 |
|---|---|---|
| A training set | The patients with early gastric cancer (EGC) who underwent radical gastrectomy at the Donghu Ward of the First Affiliated Hospital of Nanchang University | |
| A internal validation set | The patients with early gastric cancer (EGC) who underwent radical gastrectomy at the Xianghu Ward of the First Affiliated Hospital of Nanchang University | |
| A external validation set | The patients with early gastric cancer (EGC) who underwent radical gastrectomy of the Second Affiliated Hospital of Nanchang University |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse postoperative prognosis in patients with mixed-type early gastric cancer
Evaluate the incidence of adverse postoperative prognosis in patients with mixed-type early gastric cancer via the Nomogram model scoring.
Measured: From enrollment to the end of treatment at 5 years
Secondary outcomes (1)
Pathological malignancy grade
Grading criteria refer to clinical guidelines: High risk, Medium risk, Low risk.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start18 Jan 2017
- Primary completion31 Dec 2022
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed-type Early Gastric 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
- 421 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Nanchang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Han, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096947
- Sponsor's protocol ID
- FirstNanchangU-97696617
- Other IDs
- 82360112, 2024A0032
- Acronym
- MTEGC
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The secure sharing of Individual Participant Data (IPD) must adhere to the principles of "privacy protection first, minimum necessity, and full-process controllability". It should integrate technical safeguards (such as de-identification and encryption), management norms (including access control and protocol constraints), and compliance reviews. This approach aims to promote collaboration in medical research while maximizing the protection of participants' rights and interests.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multifactor Prediction Model for Non-curative Outcomes in Mixed-type Early Gastric Cancer: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07096947
- Acronym / sponsor ID
- MTEGC / FirstNanchangU-97696617
- Conditions
- Mixed-type Early Gastric Cancer
- Keywords
- Mixed-type Early Gastric Cancer, Non-curative Outcomes, Nomogram Model, Prognosis, Dual-center Retrospective Cohort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 421 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 18 Jan 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 31 Jul 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 dual-center study is to identify the most valuable predictive factors (MVPs) for non-curable mixed-type early gastric cancer (NC-MTEGC) and develop a nomogram scoring model to assist surgeons in formulating precise postoperative combined radiochemotherapy strategies in patients with mixed-type early gastric cancer (MTEGC) who have undergone radical surgical resection. The main question it aims to answer is:
What are the most valuable predictive factors for NC-MTEGC, and can a nomogram scoring model developed based on these factors effectively assist in formulating precise postoperative combined radiochemotherapy strategies?
Patients with MTEGC who have undergone radical surgical resection (including 160 in the training group, 151 in the internal validation set from the First Affiliated Hospital of Nanchang University, and 110 in the external test cohort from the Second Affiliated Hospital of Nanchang University) will be included in the study. The Least Absolute Shrinkage and Selection Operator (LASSO) algorithm will be used to assess key predictive indicators, a nomogram prediction model will be developed based on logistic regression, and an NC-MTEGC risk score model will be constructed. Meanwhile, the model's discriminatory ability, calibration, and clinical utility will be comprehensively validated across the three cohorts, with follow-up for relevant conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A training set | – | –The patients with early gastric cancer (EGC) who underwent radical gastrectomy at the Donghu Ward of the First Affiliated Hospital of Nanchang University |
| A internal validation set | – | –The patients with early gastric cancer (EGC) who underwent radical gastrectomy at the Xianghu Ward of the First Affiliated Hospital of Nanchang University |
| A external validation set | – | –The patients with early gastric cancer (EGC) who underwent radical gastrectomy of the Second Affiliated Hospital of Nanchang University |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- mixed-type early gastric cancer
Key inclusion criteria (3 listed)
- Mixed-type early gastric cancer (MTEGC);
- Receive a surgical procedure;
- Complete preoperative data.
Key exclusion criteria (7 listed)
- Received neoadjuvant therapy;
- History of gastrectomy;
- Previous cancer or residual gastric cancer (GC);
- Distant metastasis at diagnosis;
- Incomplete preoperative data;
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 incidence of adverse postoperative prognosis in patients with mixed-type early gastric cancer
Time frame: From enrollment to the end of treatment at 5 years
Evaluate the incidence of adverse postoperative prognosis in patients with mixed-type early gastric cancer via the Nomogram model scoring.
1 secondary outcome
Pathological malignancy grade
Time frame: Periprocedural
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 31 Jul 2025.
- Individual participant dataSharing planned: No. The secure sharing of Individual Participant Data (IPD) must adhere to the principles of "privacy protection first, minimum necessity, and full-process controllability". It should integrate technical safeguards (such as de-identification and encryption), management norms (including access control and protocol constraints), and compliance reviews. This approach aims to promote collaboration in medical research while maximizing the protection of participants' rights and interests.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mixed-type Early Gastric Cancer, run by The First Affiliated Hospital of Nanchang University 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 3 inclusion and 7 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 31 Jul 2025. 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?
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?
The incidence of adverse postoperative prognosis in patients with mixed-type early gastric cancer (time frame: From enrollment to the end of treatment at 5 years). 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 31 Jul 2025; AzTrials last refreshed its copy on 30 Oct 2026.