Risk Factors and Prediction Model of Cancer-associated Venous Thromboembolism

February 6, 2023 updated by: Yongsheng Jiang
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 Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

700

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
      • Wuhan, China
        • Recruiting
        • Tongji 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

Non-Probability Sample

Study Population

Patients diagnosed with malignant tumors in Tongji Hospital in Wuhan.

Description

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.

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

Cohorts and Interventions

Group / Cohort
cancer patients with venous thrombosis
cancer patients without venous thrombosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cancer-associated venous thrombosis
Time Frame: 12 months since receiving anti-cancer therapy
including deep venous thrombosis and pulmonary embolism
12 months since receiving anti-cancer therapy

Collaborators and Investigators

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

Sponsor

Yongsheng Jiang

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 (Actual)

December 23, 2022

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-IRB20221313

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

If needed, we will share the study protocol, informed consent form and clinical study report.

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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