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

Stomach Neoplasms Clinical Trial

— EMPUPDTGCP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04953585
• Other study ID #: NO.81501826
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: January 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Procedure:
• radical gastrectomy
According to the size and location of the tumor, the appropriate surgical method was selected for radical gastrectomy

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xi 'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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