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

A Prospective Clinical Study to Validate a Preoperative Risk Scoring Model for Lymph Node Metastasis in Gastric Cancer Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06339307

Enrollment

120

Registered

2024-04-01

Start date

2024-02-15

Completion date

2025-04-21

Last updated

2025-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Lymph Node Metastasis, Predictive Cancer Model

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

China

Outcome results