Venous Thromboembolism in Advanced Lung Cancer (RIVAL)

July 9, 2018 updated by: Guangdong Provincial People's Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

1400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guagndong
      • Guangzhou, Guagndong, China, 510080
        • Guangdong General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients diagnosed with advanced staged lung cancer with written informed consent.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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 Names:
  • advance lung cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Investigators

  • Principal Investigator: ZHEN WANG, Guangdong General Hospital, Guangdong Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2018

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

May 25, 2018

First Submitted That Met QC Criteria

July 9, 2018

First Posted (Actual)

July 10, 2018

Study Record Updates

Last Update Posted (Actual)

July 10, 2018

Last Update Submitted That Met QC Criteria

July 9, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No.GDREC 2018009H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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