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

Recruiting

• Conditions: Predictive Cancer Model; Gastric Cancer; Lymph Node Metastasis

• Registration Number: NCT06339307
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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.

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 Timeline

• Status Verified: 2024-02
• Study Start: 2024-02-15
• Study First Submitted: 2024-03-17
• Study First Submitted QC: 2024-03-24
• Last Update Submitted: 2024-03-24
• Study First Posted: 2024-04-01
• Last Update Posted: 2024-04-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
lymph node metastasis	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.

Trial Locations

Locations (1)

Cancer Hospital of Tianjin Medical University; 🇨🇳 Tianjin, Tianjin, China