Association Between Multiple Coagulation-related Factors and Lymph Node Metastasis in Patients With Gastric Cancer: A Retrospective Cohort Study (MA)

October 21, 2022 updated by: Feng Tian, Shandong Provincial Hospital
We initially selected a total of 1128 patients with primary gastric cancer who presented at Shandong Provincial Hospital between January 2018 and October 2022, and retrospectively collected their clinical and pathological data. And retrospectively analyzed preoperative baseline characteristics, preoperative laboratory tests, and postoperative pathological results for these patients

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

516

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250021
        • Recruiting
        • Shandong Provincial Hospital
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with primary gastric cancer

Description

Inclusion Criteria:

  1. patients with primary gastric malignant tumors,
  2. patients who underwent radical resection of gastric cancer,
  3. patients with a postoperative pathology of adenocarcinoma or signet ring cell carcinoma according to the WTO pathological classification,

Exclusion Criteria:

  1. patients who have distant metastases, such as liver or lung metastases, were found on preoperative ultrasound and computed tomography (CT) examinations,
  2. patients who have received preoperative neoadjuvant chemotherapy,
  3. patients who take anticoagulant drugs (such as aspirin) prior to surgery,
  4. patients who had any previous coagulation disorder.

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
N0
gastric cancer patients with no lymph node metastasis
Diagnostic test: coagulation-related factors
We retrospectively evaluated the relationship between lymph node metastasis and coagulation-related factors in 516 patients with T4a stage gastric cancer.
N+
gastric cancer patients with lymph node metastasis, including patients with N1, N2 and N3 stage cancer
Diagnostic test: coagulation-related factors
We retrospectively evaluated the relationship between lymph node metastasis and coagulation-related factors in 516 patients with T4a stage gastric cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative coagulation-related factors (MA values) of patients
Time Frame: Three years
MA values(mm). Measure the data of preoperative MA values in 516 gastric cancer patients to see wether this indicator correlated with tumor stage in patients with gastric cancer.
Three years
Preoperative coagulation-related factors (platelet counts) of patients
Time Frame: Three years
Platelet counts（x10^9/L). Measure the data of preoperative platelet counts in 516 gastric cancer patients to see wether this indicator correlated with tumor stage in patients with gastric cancer.
Three years
Preoperative coagulation-related factors (fibrinogen levels) of patients
Time Frame: Three years
Fibrinogen levels (g/L). Measure the data of preoperative fibrinogen levels in 516 gastric cancer patients to see wether this indicator correlated with tumor stage in patients with gastric cancer.
Three years
Preoperative coagulation-related factors (D-dimer) of patients
Time Frame: Three years
D-dimer (mg/L). Measure the data of preoperative D-dimer in 516 gastric cancer patients to see wether this indicator correlated with tumor stage in patients with gastric cancer.
Three years
Postoperative pathological results of tumor T stage.
Time Frame: Three years
Recording the postoperative pathological tumor T stage in 516 patients with gastric cancer.
Three years
Postoperative pathological results of tumor N stage.
Time Frame: Three years.
Recording the postoperative pathological tumor N stage in 516 patients with gastric cancer.
Three years.

Collaborators and Investigators

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

Sponsor

Shandong Provincial Hospital

Investigators

  • Principal Investigator: Feng Tian, Doctor, Shandong Provincial Hospital

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, 2018

Primary Completion (Anticipated)

October 31, 2022

Study Completion (Anticipated)

October 31, 2022

Study Registration Dates

First Submitted

October 18, 2022

First Submitted That Met QC Criteria

October 21, 2022

First Posted (Actual)

October 25, 2022

Study Record Updates

Last Update Posted (Actual)

October 25, 2022

Last Update Submitted That Met QC Criteria

October 21, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FTian

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

After the article is published, the original data can be obtained by contacting the project leader.

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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