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

NCT04953585 | Completed

• 1 other identifier: NO.81501826
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Stomach Neoplasms

Outcome Measures

Primary Outcomes (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

Study Arms (2)

Normal D-dimer group

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

Procedure: radical gastrectomy

Elevated D-dimer group

preoperative plasma D-dimer levels greater than 1mg/L

Procedure: radical gastrectomy

Interventions

radical gastrectomy PROCEDURE

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

Elevated D-dimer group; Normal D-dimer group

Eligibility Criteria

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

Study Population

Patients first diagnosed with gastric cancer and suitable for radical resection

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

The First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

the pathological specimen after surgical resection

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Dongmei Diao

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: July 8, 2021
• Study Start: January 1, 2019
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2021
• Last Updated: July 8, 2021

Record last verified: 2021-01

Locations

CN (1)