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

Sponsor
First Affiliated Hospital Xi'an Jiaotong University (Other)
Overall Status
Completed
CT.gov ID
NCT04953585
Collaborator
(none)
1,000
1
24
41.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: radical gastrectomy

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 Design

Study Type:
Observational
Actual Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Effectiveness of Managing Suspected Metastasis and Progress Using Plasma D-dimer Testing in Gastric Cancer Patients
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Jan 1, 2019
Actual Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

  • ageā‰„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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Xi 'an Jiaotong University Xi'an Shaanxi China 710061

Sponsors and Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier:
NCT04953585
Other Study ID Numbers:
  • NO.81501826
First Posted:
Jul 8, 2021
Last Update Posted:
Jul 8, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 8, 2021