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Trial record 2 of 77263 for:    Neoplasms

Venous Thromboembolism in Advanced Lung Cancer (RIVAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03581708
Recruitment Status : Not yet recruiting
First Posted : July 10, 2018
Last Update Posted : July 10, 2018
Information provided by (Responsible Party):
Guangdong General Hospital

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.

Condition or disease Intervention/treatment
Lung Neoplasms Venous Thromboembolism Other: 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.

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Study Type : Observational
Estimated Enrollment : 1400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real-world Study of the Incidence and Risk Factors of Venous Thromboembolism (VTE) in Chinese Advanced Stage Lung Cancer
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort Intervention/treatment
advanced lung cancer
Patients diagnosed with advanced lung cancer
Other: lung cancer
If the patient is diagnosed with lung cancer in advanced stage, he/she will be followed up for VTE incidence
Other Name: advance lung cancer

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. VTE incidence [ Time Frame: 12 months ]
    VTE incidence in advanced lung cancer.

  2. VTE and overall survival [ Time Frame: 12 months ]
    The influence on overall survival by VTE.

Biospecimen Retention:   Samples With DNA
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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients diagnosed with advanced staged lung cancer with written informed consent.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03581708

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Contact: ZHEN WANG, PhD 862083827812 ext 50811
Contact: XIAOLING CHEN 8620-83827812 ext 50816

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China, Guagndong
Guangdong General Hospital Not yet recruiting
Guangzhou, Guagndong, China, 510080
Contact: ZHEN WANG, PhD    862083827812 ext 50811   
Contact: XIAOLING CHEN    862083827812 ext 50812   
Principal Investigator: ZHEN WANG, PHD         
Sponsors and Collaborators
Guangdong General Hospital
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Principal Investigator: ZHEN WANG Guangdong General Hospital, Guangdong Academy of Medical Sciences

Publications of Results:
Other Publications:
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Responsible Party: Guangdong General Hospital Identifier: NCT03581708     History of Changes
Other Study ID Numbers: No.GDREC 2018009H
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Guangdong General Hospital:
lung cancer
Venous Thromboembolism

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Venous Thromboembolism
Lung Diseases
Respiratory Tract Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases