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

Xi'an Jiaotong University

Status: Completed

Conditions: Stomach Neoplasms

Treatments: Procedure: radical gastrectomy

Study type: Observational

Funder types: Other

Identifiers

NCT04953585

NO.81501826

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 2 patient groups

Normal D-dimer group

Description:

preoperative plasma D-dimer levels less than or equal to 1mg/L

Treatment:

Procedure: radical gastrectomy

Elevated D-dimer group

Description:

preoperative plasma D-dimer levels greater than 1mg/L

Treatment:

Procedure: radical gastrectomy