A Prospective Clinical Study to Validate a Preoperative Risk Scoring Model for Lymph Node Metastasis in Gastric Cancer Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Predictive Cancer Model
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- lymph node metastasis
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Primary gastric adenocarcinoma;
- •Curative surgery (with R0 resection, excluding palliative surgery and cases with distant metastasis).
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.