Risk Factors and Prediction Model of Cancer-associated Venous Thromboembolism

NCT ID: NCT05729464

Last Updated: 2023-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-23

Study Completion Date

2023-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Venous Thromboses Neoplasms

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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cancer patients with venous thrombosis

No interventions assigned to this group

cancer patients without venous thrombosis

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yongsheng Jiang

OTHER

Sponsor Role lead

Responsible Party

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Yongsheng Jiang

Department of Oncology ,Tongji Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Tongji Hospital

Wuhan, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yongsheng Jiang, doctor

Role: CONTACT

027-83662356

Facility Contacts

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Yongsheng Jiang, doctor

Role: primary

02783662356

References

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Mulder FI, Bosch FTM, van Es N. Primary Thromboprophylaxis in Ambulatory Cancer Patients: Where Do We Stand? Cancers (Basel). 2020 Feb 5;12(2):367. doi: 10.3390/cancers12020367.

Reference Type BACKGROUND
PMID: 32033438 (View on PubMed)

Lloyd AJ, Dewilde S, Noble S, Reimer E, Lee AYY. What Impact Does Venous Thromboembolism and Bleeding Have on Cancer Patients' Quality of Life? Value Health. 2018 Apr;21(4):449-455. doi: 10.1016/j.jval.2017.09.015. Epub 2017 Nov 10.

Reference Type BACKGROUND
PMID: 29680102 (View on PubMed)

Mahajan A, Brunson A, White R, Wun T. The Epidemiology of Cancer-Associated Venous Thromboembolism: An Update. Semin Thromb Hemost. 2019 Jun;45(4):321-325. doi: 10.1055/s-0039-1688494. Epub 2019 Apr 30.

Reference Type BACKGROUND
PMID: 31041801 (View on PubMed)

Mulder FI, Horvath-Puho E, van Es N, van Laarhoven HWM, Pedersen L, Moik F, Ay C, Buller HR, Sorensen HT. Venous thromboembolism in cancer patients: a population-based cohort study. Blood. 2021 Apr 8;137(14):1959-1969. doi: 10.1182/blood.2020007338.

Reference Type BACKGROUND
PMID: 33171494 (View on PubMed)

Fernandes CJ, Morinaga LTK, Alves JL Jr, Castro MA, Calderaro D, Jardim CVP, Souza R. Cancer-associated thrombosis: the when, how and why. Eur Respir Rev. 2019 Mar 27;28(151):180119. doi: 10.1183/16000617.0119-2018. Print 2019 Mar 31.

Reference Type BACKGROUND
PMID: 30918022 (View on PubMed)

Riondino S, Ferroni P, Zanzotto FM, Roselli M, Guadagni F. Predicting VTE in Cancer Patients: Candidate Biomarkers and Risk Assessment Models. Cancers (Basel). 2019 Jan 15;11(1):95. doi: 10.3390/cancers11010095.

Reference Type BACKGROUND
PMID: 30650562 (View on PubMed)

Kim AS, Khorana AA, McCrae KR. Mechanisms and biomarkers of cancer-associated thrombosis. Transl Res. 2020 Nov;225:33-53. doi: 10.1016/j.trsl.2020.06.012. Epub 2020 Jul 6.

Reference Type BACKGROUND
PMID: 32645431 (View on PubMed)

Hisada Y, Mackman N. Cancer-associated pathways and biomarkers of venous thrombosis. Blood. 2017 Sep 28;130(13):1499-1506. doi: 10.1182/blood-2017-03-743211. Epub 2017 Aug 14.

Reference Type BACKGROUND
PMID: 28807983 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18216292 (View on PubMed)

Key NS, Khorana AA, Kuderer NM, Bohlke K, Lee AYY, Arcelus JI, Wong SL, Balaban EP, Flowers CR, Francis CW, Gates LE, Kakkar AK, Levine MN, Liebman HA, Tempero MA, Lyman GH, Falanga A. Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer: ASCO Clinical Practice Guideline Update. J Clin Oncol. 2020 Feb 10;38(5):496-520. doi: 10.1200/JCO.19.01461. Epub 2019 Aug 5.

Reference Type BACKGROUND
PMID: 31381464 (View on PubMed)

Mulder FI, Candeloro M, Kamphuisen PW, Di Nisio M, Bossuyt PM, Guman N, Smit K, Buller HR, van Es N; CAT-prediction collaborators. The Khorana score for prediction of venous thromboembolism in cancer patients: a systematic review and meta-analysis. Haematologica. 2019 Jun;104(6):1277-1287. doi: 10.3324/haematol.2018.209114. Epub 2019 Jan 3.

Reference Type BACKGROUND
PMID: 30606788 (View on PubMed)

Other Identifiers

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TJ-IRB20221313

Identifier Type: -

Identifier Source: org_study_id

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