A Prospective Clinical Study to Validate a Preoperative Risk Scoring Model for LNM in GC Patients

September 14, 2025 updated by: Tianjin Medical University Cancer Institute and Hospital

A Prospective Clinical Study to Validate a Preoperative Risk Scoring Model for Lymph Node Metastasis in Gastric Cancer Patients

In our prior research, a risk scoring model for the occurrence of lymph node metastasis in patients who underwent radical gastrectomy for gastric cancer was established. To further validate this scoring model, a prospective study has been designed with the aim of prospectively assessing the model's clinical applicability.

Study Overview

Status

Completed

Conditions

Detailed Description

The study was a single-centre, prospective study. Data prospectively accrued were employed to evaluate the concordance between observed patient outcomes, with respect to lymph node metastasis status post-curative gastrectomy, and the prognostications tendered by the established risk scoring model, thereby appraising the model's clinical applicability and validity.

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Cancer Hospital of Tianjin Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who were diagnosed with gastric cancer pathologically and underwent curative gastrectomy.

Description

Inclusion Criteria:

  1. Primary gastric adenocarcinoma;
  2. Curative surgery (with R0 resection, excluding palliative surgery and cases with distant metastasis).

Exclusion Criteria:

  1. Patients with autoimmune diseases, inflammation, or hematological disorders;
  2. Patients with a history of or concurrent other cancers;
  3. Presence of active infection and inflammation (based on WBC count, patients with count of 10×10^9 or higher should be evaluated through medical record examination for the presence of infection);
  4. Active bleeding (as determined by endoscopic ultrasound and HGB ≤ 90);
  5. Post neoadjuvant radiotherapy or chemotherapy;
  6. History of blood transfusion, corticosteroid use, or leukocyte-stimulating medications within the past month prior to blood draw;
  7. Incomplete clinical and pathological data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
with LNM
Patients with gastric cancer who underwent curative gastrectomy and developed lymph node metastasis.
without LNM
Patients with gastric cancer who underwent curative gastrectomy and did not develop lymph node metastasis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lymph node metastasis
Time Frame: 1 month after curative surgery
Collect postoperative pathological data from gastric cancer patients who have undergone curative gastrectomy to determine the occurrence of lymph node metastasis.
1 month after curative surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2024

Primary Completion (Actual)

April 21, 2024

Study Completion (Actual)

April 21, 2025

Study Registration Dates

First Submitted

March 17, 2024

First Submitted That Met QC Criteria

March 24, 2024

First Posted (Actual)

April 1, 2024

Study Record Updates

Last Update Posted (Estimated)

September 18, 2025

Last Update Submitted That Met QC Criteria

September 14, 2025

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DJY004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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