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

• Sponsor: Shandong Provincial Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05592925
• Collaborator: (none)
• Enrollment: 516
• Location: 1
• Anticipated Duration (Months): 58
• Patients Per Site Per Month: 8.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer Stage; Lymph Node Metastasis	Diagnostic Test: coagulation-related factors

Study Design

• Study Type: Observational
• Anticipated Enrollment: 516 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Association Between Multiple Coagulation-related Factors and Lymph Node Metastasis in Patients With Gastric Cancer: A Retrospective Cohort Study
• Actual Study Start Date: Jan 1, 2018
• Anticipated Primary Completion Date: Oct 31, 2022
• Anticipated Study Completion Date: Oct 31, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Preoperative coagulation-related factors (MA values) of patients [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.

2. Preoperative coagulation-related factors (platelet counts) of patients [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.

3. Preoperative coagulation-related factors (fibrinogen levels) of patients [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.

4. Preoperative coagulation-related factors (D-dimer) of patients [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.

5. Postoperative pathological results of tumor T stage. [Three years]

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

6. Postoperative pathological results of tumor N stage. [Three years.]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shandong Provincial Hospital	Jinan	Shandong	China	250021

Sponsors and Collaborators

• Shandong Provincial Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Feng Tian, Director, Shandong Provincial Hospital
• ClinicalTrials.gov Identifier: NCT05592925
• Other Study ID Numbers: FTian
• First Posted: Oct 25, 2022
• Last Update Posted: Oct 25, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Feng Tian, Director, Shandong Provincial Hospital: gastric cancer; lymph node metastasis; maximum amplitude; prognostic factor
• Additional relevant MeSH terms: Neoplasm Metastasis; Stomach Neoplasms; Lymphatic Metastasis

Study Results

No Results Posted as of Oct 25, 2022