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

NCT05592925 | Unknown

• 1 other identifier: FTian
• Study Type: observational
• Target: 516
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastric Cancer Stage; Lymph Node Metastasis

Keywords

gastric cancer; lymph node metastasis; maximum amplitude; prognostic factor

Outcome Measures

Primary Outcomes (6)

• Preoperative coagulation-related factors (MA values) of patients

  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

  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

  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

  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.

  Recording the postoperative pathological tumor T stage in 516 patients with gastric cancer.

  Three years

• Postoperative pathological results of tumor N stage.

  Recording the postoperative pathological tumor N stage in 516 patients with gastric cancer.

  Three years.

Study Arms (2)

N0

gastric cancer patients with no lymph node metastasis

Diagnostic Test: coagulation-related factors

N+

gastric cancer patients with lymph node metastasis, including patients with N1, N2 and N3 stage cancer

Diagnostic Test: coagulation-related factors

Interventions

coagulation-related factors DIAGNOSTIC_TEST

We retrospectively evaluated the relationship between lymph node metastasis and coagulation-related factors in 516 patients with T4a stage gastric cancer.

N+; N0

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with primary gastric cancer

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shandong Provincial Hospital: lead

Study Sites (1)

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

RECRUITING

MeSH Terms

Conditions

Lymphatic Metastasis; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Feng Tian, Doctor

  Shandong Provincial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Tian, Doctor

CONTACT

18866102886; tianfeng@sdu.edu.cn

Changqing Jing, Doctor

CONTACT

15168888987; jingchangqing@sdfmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 25, 2022
• Study Start: January 1, 2018
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)