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Completed

NCT Number: NCT04953585

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, 710061, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radical Gastrectomy

Procedure

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Acronym: EMPUPDTGCP

Important dates

Study start
2019
Primary completion
2019
Study completion
2021
First posted
Jul 8, 2021
Registry last updated
Jul 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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