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Risk Factors and Prediction Model of Cancer-associated Venous Thromboembolism

Sponsor
Yongsheng Jiang (Other)
Overall Status
Recruiting
CT.gov ID
NCT05729464
Collaborator
(none)
700
Enrollment
1
Location
12.2
Anticipated Duration (Months)
57.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to identify risk factors of cancer-associated venous thrombosis and develop a prediction model to assist clinicians in tailoring anticoagulant therapy.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Venous thromboembolism (VTE) is a prevalent complication in cancer patients. Compared with the general population, patients with tumors are four to seven times more likely to develop venous thrombotic events. A population-based cohort study showed that the incidence of VTE in these patients has increased steadily over the past decade. Cancer-associated thrombosis may result in discontinuation of antineoplastic therapy, decreased quality of life, and increased mortality. Clinical trials indicate that prophylactic anticoagulation leads to a significantly lower rate of thrombotic disorders. However, due to the fact that thromboprophylaxis treatment increases the risk of bleeding complications and that the risk of VTE varies widely among individuals, only patients at high risk of thrombosis will benefit from primary thromboprophylaxis. In this setting, the use of anticoagulant drugs is challenging. So, the purpose of this study is to identify risk factors of cancer-associated venous thrombosis and develop a prediction model to assist clinicians in tailoring anticoagulant therapy.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    700 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Risk Factors and Prediction Model of Cancer-associated Venous Thromboembolism
    Actual Study Start Date :
    Dec 23, 2022
    Anticipated Primary Completion Date :
    Jul 1, 2023
    Anticipated Study Completion Date :
    Dec 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    cancer patients with venous thrombosis
    cancer patients without venous thrombosis

    Outcome Measures

    Primary Outcome Measures

    1. cancer-associated venous thrombosis [12 months since receiving anti-cancer therapy]

      including deep venous thrombosis and pulmonary embolism

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • with a histological diagnosis of cancer.
    Exclusion Criteria:

    • received long-term anticoagulant therapy;

    • without a clear primary site of malignancy;

    • had a follow-up of fewer than 6 months.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tongji Hospital Wuhan China

    Sponsors and Collaborators

    • Yongsheng Jiang

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Yongsheng Jiang, Department of Oncology ,Tongji Hospital, Tongji Hospital
    ClinicalTrials.gov Identifier:
    NCT05729464
    Other Study ID Numbers:
    • TJ-IRB20221313
    First Posted:
    Feb 15, 2023
    Last Update Posted:
    Feb 15, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Thrombosis
    Thromboembolism
    Venous Thromboembolism
    Venous Thrombosis

    Study Results

    No Results Posted as of Feb 15, 2023