NCT05729464

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 23, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

February 6, 2023

Last Update Submit

February 6, 2023

Conditions

Venous ThrombosesNeoplasms

Outcome Measures

Primary Outcomes (1)

  • cancer-associated venous thrombosis

    including deep venous thrombosis and pulmonary embolism

    12 months since receiving anti-cancer therapy

Study Arms (2)

cancer patients with venous thrombosis

cancer patients without venous thrombosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with malignant tumors in Tongji Hospital in Wuhan.

You may qualify if:

  • with a histological diagnosis of cancer.

You may not qualify if:

  • received long-term anticoagulant therapy;
  • without a clear primary site of malignancy;
  • had a follow-up of fewer than 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, China

RECRUITING

Related Publications (11)

  • 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.

    PMID: 32033438BACKGROUND

  • 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.

    PMID: 29680102BACKGROUND

  • 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.

    PMID: 31041801BACKGROUND

  • 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.

    PMID: 33171494BACKGROUND

  • 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.

    PMID: 30918022BACKGROUND

  • 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.

    PMID: 30650562BACKGROUND

  • 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.

    PMID: 32645431BACKGROUND

  • 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.

    PMID: 28807983BACKGROUND

  • 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.

    PMID: 18216292BACKGROUND

  • 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.

    PMID: 31381464BACKGROUND

  • 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.

    PMID: 30606788BACKGROUND

MeSH Terms

Conditions

Venous ThrombosisNeoplasms

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Central Study Contacts

Yongsheng Jiang, doctor

CONTACT

027-83662356ysjiang.china@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Department of Oncology ,Tongji Hospital

Study Record Dates

First Submitted

February 6, 2023

First Posted

February 15, 2023

Study Start

December 23, 2022

Primary Completion

July 1, 2023

Study Completion

December 30, 2023

Last Updated

February 15, 2023

Record last verified: 2023-02

Locations

CN(1)