Clinical trial NCT03581708: Venous Thromboembolism in Advanced Lung Cancer
Official title: Real-world Study of the Incidence and Risk Factors of Venous Thromboembolism (VTE) in Chinese Advanced Stage Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Neoplasms
Venous Thromboembolism
Keywords: lung cancer
Venous Thromboembolism
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with advanced staged lung cancer with written informed consent.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: VTE incidence risk evaluation
timeFrame: 12 months
Secondary outcomes:
measure: VTE incidence
timeFrame: 12 months
measure: VTE and overall survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guagndong
Study officials:
affiliation: Guangdong General Hospital, Guangdong Academy of Medical Sciences
name: ZHEN WANG
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Wang Z, Yan HH, Yang JJ, Wang BC, Chen HJ, Zhou Q, Xu CR, Jiang BY, Wu YL. Venous thromboembolism risk factors in Chinese non-small cell lung cancer patients. Support Care Cancer. 2015 Mar;23(3):635-41. doi: 10.1007/s00520-014-2405-y. Epub 2014 Aug 27.