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

Recruiting
18 - 70 years of age
Both
Phase N/A

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Overview

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.

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.

Eligibility

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 details

Predictive Cancer Model, Gastric Cancer, Lymph Node Metastasis

NCT06339307

Tianjin Medical University Cancer Institute and Hospital

18 April 2024

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