Venous Thromboembolism in Advanced Lung Cancer
RIVAL
Real-world Study of the Incidence and Risk Factors of Venous Thromboembolism (VTE) in Chinese Advanced Stage Lung Cancer
1 other identifier
observational
1,400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2018
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedFirst Posted
Study publicly available on registry
July 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedJuly 10, 2018
May 1, 2018
2.9 years
May 25, 2018
July 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
VTE incidence
12 months
VTE and overall survival
12 months
Study Arms (1)
advanced lung cancer
Patients diagnosed with advanced lung cancer
Interventions
If the patient is diagnosed with lung cancer in advanced stage, he/she will be followed up for VTE incidence
Eligibility Criteria
Patients diagnosed with advanced staged lung cancer with written informed consent.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangdong General Hospital
Guangzhou, Guagndong, 510080, China
Related Publications (8)
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.
PMID: 18216292BACKGROUNDBlom 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.
PMID: 15701913RESULTTesselaar 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.
PMID: 17940477RESULTLevitan 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.
PMID: 10499070RESULTThodiyil PA, Kakkar AK. Variation in relative risk of venous thromboembolism in different cancers. Thromb Haemost. 2002 Jun;87(6):1076-7. No abstract available.
PMID: 12083490RESULTStein 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.
PMID: 16431186RESULTChew 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.
PMID: 18208538RESULTWang 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.
PMID: 25155313RESULT
Biospecimen
4 ml of peripheral blood is drawn from each subject and mononuclear cells are separated for DNA extraction, and mutation of Factor V Leiden will be examined.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ZHEN WANG
Guangdong General Hospital, Guangdong Academy of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2018
First Posted
July 10, 2018
Study Start
July 1, 2018
Primary Completion
June 1, 2021
Study Completion
June 1, 2022
Last Updated
July 10, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share