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

July 7, 2021 updated by: First Affiliated Hospital Xi'an Jiaotong University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xi 'an Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients first diagnosed with gastric cancer and suitable for radical resection

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal D-dimer group
preoperative plasma D-dimer levels less than or equal to 1mg/L
Procedure: radical gastrectomy
According to the size and location of the tumor, the appropriate surgical method was selected for radical gastrectomy
Elevated D-dimer group
preoperative plasma D-dimer levels greater than 1mg/L
Procedure: radical gastrectomy
According to the size and location of the tumor, the appropriate surgical method was selected for radical gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival time
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Study Chair: Dongmei Diao, The First Affiliated Hospital of Xi 'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ACTUAL)

January 1, 2019

Study Completion (ACTUAL)

January 1, 2021

Study Registration Dates

First Submitted

June 15, 2021

First Submitted That Met QC Criteria

July 7, 2021

First Posted (ACTUAL)

July 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 8, 2021

Last Update Submitted That Met QC Criteria

July 7, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NO.81501826

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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