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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06339307
• Other study ID #: DJY004
• Status: Recruiting
• Start date: February 15, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Jingyu Deng, M.D.
• Phone: +86-22-23340123
• Email: dengery[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Lymph Node Metastasis
• Lymphatic Metastasis
• Neoplasm Metastasis
• Predictive Cancer Model
• Stomach Neoplasms

Locations

Country	Name	City	State
China	Cancer Hospital of Tianjin Medical University	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lymph node metastasis	Collect postoperative pathological data from gastric cancer patients who have undergone curative gastrectomy to determine the occurrence of lymph node metastasis.	1 month after curative surgery