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

NCT ID: NCT04953585

Last Updated: 2021-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-01-01

Brief Summary

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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

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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.

Conditions

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Stomach Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Normal D-dimer group

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

radical gastrectomy

Intervention Type PROCEDURE

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

radical gastrectomy

Intervention Type PROCEDURE

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

Interventions

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radical gastrectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dongmei Diao

Role: STUDY_CHAIR

The First Affiliated Hospital of Xi 'an Jiaotong University

Locations

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The First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, China

Site Status

Countries

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China

Other Identifiers

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NO.81501826

Identifier Type: -

Identifier Source: org_study_id

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