A Clinical Prospective Study to Validate a Risk Scoring Model for the HMGC After Curative Surgery

NCT06023966 | Completed

• 1 other identifier: DJY003
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

A previous study of investigators established a risk scoring model for occurrence of postoperative hepatic metastases in patients who underwent curative gastrectomy directly without neoadjuvant therapy. In order to further validate the clinical applicability of abovementioned model, investigators designed this prospective study, which also included patients who received neoadjuvant therapy before surgery, with the aim of exploring the applicability of the risk scoring model to this group of patients.

Conditions

Predictive Cancer Model; Hepatic Metastasis; Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• hepatic metastasis

  Postoperative telephone follow-up was performed in patients with gastric cancer undergoing curative gastrectomy to determine the occurrence of hepatic metastasis.

  2 years after curative surgery

Secondary Outcomes (1)

• interval between the surgery and hepatic metastasis

  2 years after curative surgery

Study Arms (2)

with HMGC

patients with gastric cancer who developed hepatic metastasis after curative gastrectomy

without HMGC

patients with gastric cancer who did not developed hepatic metastasis after curative gastrectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patietns who were diagnosed with gastric cancer pathologically and underwent curative gastrectomy.

You may qualify if:

• Received curative gastrectomy (D2 lymph node dissection);
• Gastric cancer without distant organ metastasis, distant lymph node metastasis and peritoneal implantation (M0) confirmed by postoperative pathology;
• No hepatic tumors and other occupying diseases, no chronic diseases such as cirrhosis and hepatitis, no hepatic schistosomiasis, no hepatic echinococcosis, no hepatic tuberculosis, and no severe fatty liver disease before the curative surgery;
• No history of intraperitoneal chemotherapy;
• No other serious concomitant diseases with satisfactory organ function;
• No history of other malignant tumors;
• Comply with the protocol during the whole study period;
• Sign informed consent and permission of withdraw in the whole study period;
• Estimation the overall survival after surgery no less than 12 months;
• Consent to analysis of clinicopathological data and prognostic follow up;
• Karnofsky Performance Scores (KPS) more than 60.

You may not qualify if:

• Special histological types of gastric cancer (neuroendocrine, squamous, squamous cell, hepatoid adenocarcinoma or others);
• Gastro-esophageal junction cancer;
• Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months;
• Immunosuppressive therapists for organ transplantation;
• Seriously uncontrolled recurrent infection;
• History of other malignancies;
• No abilities of self-knowledge or mental disorders;
• Combination of other serious diseases;
• Concurrent participation in other clinical trials.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Cancer Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 5, 2023
• Study Start: September 1, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: November 20, 2025

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)