Venous Thromboembolism in Advanced Lung Cancer

Venous Thromboembolism Clinical Trial

— RIVAL  

Official title:

Real-world Study of the Incidence and Risk Factors of Venous Thromboembolism (VTE) in Chinese Advanced Stage Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03581708
• Other study ID #: No.GDREC 2018009H
• Status: Not yet recruiting
• Start date: July 2018
• Est. completion date: June 2022

Study information

• Verified date: May 2018
• Source: Guangdong General Hospital
• Contact: ZHEN WANG, PhD
• Phone: 862083827812
• Email: hunterol[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1400
• Est. completion date: June 2022
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Thromboembolism
• Venous Thromboembolism

Intervention

Other:
• lung cancer
If the patient is diagnosed with lung cancer in advanced stage, he/she will be followed up for VTE incidence

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou	Guagndong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong General Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

Blom JW, Doggen CJ, Osanto S, Rosendaal FR. Malignancies, prothrombotic mutations, and the risk of venous thrombosis. JAMA. 2005 Feb 9;293(6):715-22. — View Citation

Chew HK, Davies AM, Wun T, Harvey D, Zhou H, White RH. The incidence of venous thromboembolism among patients with primary lung cancer. J Thromb Haemost. 2008 Apr;6(4):601-8. doi: 10.1111/j.1538-7836.2008.02908.x. Epub 2008 Jan 17. — View Citation

Khorana AA, Kuderer NM, Culakova E, Lyman GH, Francis CW. Development and validation of a predictive model for chemotherapy-associated thrombosis. Blood. 2008 May 15;111(10):4902-7. doi: 10.1182/blood-2007-10-116327. Epub 2008 Jan 23. — View Citation

Levitan N, Dowlati A, Remick SC, Tahsildar HI, Sivinski LD, Beyth R, Rimm AA. Rates of initial and recurrent thromboembolic disease among patients with malignancy versus those without malignancy. Risk analysis using Medicare claims data. Medicine (Baltimo — View Citation

Stein PD, Beemath A, Meyers FA, Skaf E, Sanchez J, Olson RE. Incidence of venous thromboembolism in patients hospitalized with cancer. Am J Med. 2006 Jan;119(1):60-8. — View Citation

Tesselaar ME, Osanto S. Risk of venous thromboembolism in lung cancer. Curr Opin Pulm Med. 2007 Sep;13(5):362-7. Review. — View Citation

Thodiyil PA, Kakkar AK. Variation in relative risk of venous thromboembolism in different cancers. Thromb Haemost. 2002 Jun;87(6):1076-7. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VTE incidence risk evaluation	Real world VTE incidence risk evaluation in advanced lung cancer. Establish and validate VTE risk predictive model in Chinese advanced lung cancer.	12 months
Secondary	VTE incidence	VTE incidence in advanced lung cancer.	12 months
Secondary	VTE and overall survival	The influence on overall survival by VTE.	12 months