Venous Thromboembolism in Advanced Lung Cancer

Overview

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

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2021

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.

Interventions

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

Arms, Groups and Cohorts

  • advanced lung cancer
    • Patients diagnosed with advanced lung cancer

Clinical Trial Outcome Measures

Primary Measures

  • VTE incidence risk evaluation
    • Time Frame: 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 Measures

  • VTE incidence
    • Time Frame: 12 months
    • VTE incidence in advanced lung cancer.
  • VTE and overall survival
    • Time Frame: 12 months
    • The influence on overall survival by VTE.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Guangdong Provincial People’s Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • ZHEN WANG, Principal Investigator, Guangdong General Hospital, Guangdong Academy of Medical Sciences
  • Overall Contact(s)
    • ZHEN WANG, PhD, 862083827812, hunterol@163.com

References

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.

Citations Reporting on Results

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.

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

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 (Baltimore). 1999 Sep;78(5):285-91.

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

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.

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.

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.

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