Venous Thromboembolism in Advanced Lung Cancer

NCT ID: NCT03581708

Last Updated: 2018-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-31

Study Completion Date

2022-06-30

Brief Summary

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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

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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.

Conditions

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Lung Neoplasms Venous Thromboembolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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advanced lung cancer

Patients diagnosed with advanced lung cancer

lung cancer

Intervention Type OTHER

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

Interventions

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lung cancer

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

Intervention Type OTHER

Other Intervention Names

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advance lung cancer

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ZHEN WANG

Role: PRINCIPAL_INVESTIGATOR

Guangdong General Hospital, Guangdong Academy of Medical Sciences

Locations

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Guangdong General Hospital

Guangzhou, Guagndong, China

Site Status

Countries

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China

Central Contacts

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ZHEN WANG, PhD

Role: CONTACT

862083827812 ext. 50811

XIAOLING CHEN

Role: CONTACT

8620-83827812 ext. 50816

Facility Contacts

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ZHEN WANG, PhD

Role: primary

862083827812 ext. 50811

XIAOLING CHEN

Role: backup

862083827812 ext. 50812

References

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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.

Reference Type BACKGROUND
PMID: 18216292 (View on PubMed)

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. doi: 10.1001/jama.293.6.715.

Reference Type RESULT
PMID: 15701913 (View on PubMed)

Tesselaar ME, Osanto S. Risk of venous thromboembolism in lung cancer. Curr Opin Pulm Med. 2007 Sep;13(5):362-7. doi: 10.1097/MCP.0b013e328209413c.

Reference Type RESULT
PMID: 17940477 (View on PubMed)

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. doi: 10.1097/00005792-199909000-00001.

Reference Type RESULT
PMID: 10499070 (View on PubMed)

Thodiyil PA, Kakkar AK. Variation in relative risk of venous thromboembolism in different cancers. Thromb Haemost. 2002 Jun;87(6):1076-7. No abstract available.

Reference Type RESULT
PMID: 12083490 (View on PubMed)

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. doi: 10.1016/j.amjmed.2005.06.058.

Reference Type RESULT
PMID: 16431186 (View on PubMed)

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.

Reference Type RESULT
PMID: 18208538 (View on PubMed)

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.

Reference Type RESULT
PMID: 25155313 (View on PubMed)

Other Identifiers

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No.GDREC 2018009H

Identifier Type: -

Identifier Source: org_study_id

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