Venous Thromboembolism in Advanced Lung Cancer

• Conditions: Venous Thromboembolism; Lung Neoplasms
• Interventions: Other: lung cancer

• Registration Number: NCT03581708
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief Summary

This is a prospective observatory clinical study, aiming to establish and validate venous thromboembolism risk model in Chinese advanced non-small cell lung cancer.

Detailed Description

VTE has high incidence in lung cancer and increases the mortality. Appropriate preventive measures contribute to 50% increase of incidence. The investigators are to investigate the VTE in advanced non-small cell lung cancer and delineate the risk factors to establish a VTE risk model system helping clinicians to differentiate VTE high risk population and apply early prevention in order to reduce the incidence of VTE.

Study Timeline

• Status Verified: 2018-05
• Study First Submitted: 2018-05-25
• Study Start: 2018-07
• Study First Submitted QC: 2018-07-09
• Last Update Submitted: 2018-07-09
• Study First Posted: 2018-07-10
• Last Update Posted: 2018-07-10
• Primary Completion: 2021-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

• Age ≥ 18 years at the time of screening.
• Eastern Cooperative Oncology Group performance status of ≤ 2.
• Written informed consent obtained from the patient.
• Histologically and cytologically documented Stage 3B-4 lung cancer (according to Version 8 of the International Association for the Study of Lung Cancer Staging system).
• Patients with stage 1 to 3, who undergo radical therapy with disease free survival (DFS) >12 months.
• Willingness and ability to comply with scheduled visits and other study procedures.

Exclusion Criteria

• History of another primary malignancy except for malignancy treated with curative intent with known active disease ≥ 5 years before date of the informed consent.
• Without signed informed consent.
• Unwillingness or inability to comply with scheduled visits or other study procedures.
• Previously diagnosed with VTE before signing informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
advanced lung cancer	lung cancer	Patients diagnosed with advanced lung cancer

Primary Outcome Measures

Name	Time	Method
VTE incidence risk evaluation	12 months	Real world VTE incidence risk evaluation in advanced lung cancer. Establish and validate VTE risk predictive model in Chinese advanced lung cancer.

Secondary Outcome Measures

Name	Time	Method
VTE incidence	12 months	VTE incidence in advanced lung cancer.
VTE and overall survival	12 months	The influence on overall survival by VTE.

Trial Locations

Locations (1)

Guangdong General Hospital; 🇨🇳 Guangzhou, Guagndong, China