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

NCT06339307 | Completed

• 1 other identifier: DJY004
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Predictive Cancer Model; Gastric Cancer; Lymph Node Metastasis

Outcome Measures

Primary Outcomes (1)

• lymph node metastasis

  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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients with autoimmune diseases, inflammation, or hematological disorders;
• Patients with a history of or concurrent other cancers;
• 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);
• Active bleeding (as determined by endoscopic ultrasound and HGB ≤ 90);
• Post neoadjuvant radiotherapy or chemotherapy;
• History of blood transfusion, corticosteroid use, or leukocyte-stimulating medications within the past month prior to blood draw;
• Incomplete clinical and pathological data.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Cancer Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Stomach Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: April 1, 2024
• Study Start: February 15, 2024
• Primary Completion: April 21, 2024
• Study Completion: April 21, 2025
• Last Updated: September 18, 2025

Record last verified: 2024-02

Locations

CN (1)