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

Tianjin Medical University

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT06339307

DJY004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

120 participants in 2 patient groups

with LNM

Description:

Patients with gastric cancer who underwent curative gastrectomy and developed lymph node metastasis.

without LNM

Description:

Patients with gastric cancer who underwent curative gastrectomy and did not develop lymph node metastasis.