Effectiveness of Managing Suspected Metastasis and Progress Using Plasma D-dimer Testing in Gastric Cancer Patients

Completed

• Conditions: Stomach Neoplasms
• Interventions: Procedure: radical gastrectomy

• Registration Number: NCT04953585
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

For prognosis evaluation, investigators enroll gastric cancer patients who underwent radical gastrectomy and collect the laboratory examination and clinicopathological characteristics. Then independent risk factors for overall survival will be analysed. For predicting efficacy evaluation, investigators also collect information of patients first diagnosed with metastases. Diagnostic efficacy is analysed by receiver operator characteristic curve method.

Detailed Description

To investigate the novel predictive value of coagulation factors for postoperative outcomes after radical gastrectomy in patients with gastric cancer, investigators enroll patients with a pathologically confirmed diagnosis of gastric cancer who underwent radical gastrectomy between January 2021 and february 2017. Patients follow up data were obtained by regular follow-up. The most recent preoperative laboratory tests and clinicopathological characteristics were evaluated. Patients are devided into two groups according to our target indicator. The 5-year overall survival rate is analysed by Kaplan-Meier method. The independent risk factors for overall survival are analysed by Cox proportional hazard regression method. Investigators hypothesized that the target factor is closely related to disease progression. Whether it can be used as a tumor marker to predict metastasis is to be studied. Investigators collect laboratory examination including tumor markers of patients first diagnosed with metastases. Diagnostic efficacy is analysed and compared by receiver operator characteristic curve method.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-01-01
• Status Verified: 2021-01
• Study Completion: 2021-01-01
• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-07-07
• Last Update Submitted: 2021-07-07
• Study First Posted: 2021-07-08
• Last Update Posted: 2021-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• all patients were newly diagnosed with gastric cancer;
• all patients were pathologically diagnosed;
• all patients had pre-treatment coagulation test;
• stage I-IV disease;
• age≥18 years

Exclusion Criteria

• accompanying or secondary to other tumors;
• had history of venous thrombosis or received any anti-coagulation treatment;
• acute infection or intravascular disseminated coagulation;
• pregnancy or lactation;
• history of neoadjuvant chemotherapy;
• Lost to follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal D-dimer group	radical gastrectomy	preoperative plasma D-dimer levels less than or equal to 1mg/L
Elevated D-dimer group	radical gastrectomy	preoperative plasma D-dimer levels greater than 1mg/L

Primary Outcome Measures

Name	Time	Method
overall survival time	From date of radical gastrectomy until the date of last follow-up or date of death from gastric cancer, whichever came first, assessed up to 48 months	From date of radical gastrectomy until the date of last follow-up or date of death from gastric cancer, whichever came first, assessed up to 48 months

Trial Locations

Locations (1)

The First Affiliated Hospital of Xi 'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China