Venous ThrombosesNCT05729464
Risk Factors and Prediction Model of Cancer-associated Venous Thromboembolism
An observational study of Venous Thromboses and Neoplasms, run by Yongsheng Jiang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboses, Neoplasms
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2022to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with malignant tumors in Tongji Hospital in Wuhan.
Who may be able to join
- with a histological diagnosis of cancer.
Who cannot join
- received long-term anticoagulant therapy;
- without a clear primary site of malignancy;
- had a follow-up of fewer than 6 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan
Yongsheng Jiang, doctor, 02783662356, ysjiang@163.com
About this study
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.
Read the 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.
- Conditions
- Venous Thromboses, Neoplasms
- Medical subject headings
- Venous Thrombosis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cancer patients with venous thrombosis | Not described | |
| cancer patients without venous thrombosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
cancer-associated venous thrombosis
including deep venous thrombosis and pulmonary embolism
Measured: 12 months since receiving anti-cancer therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start23 Dec 2022
- Primary completion1 Jul 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Venous ThrombosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yongsheng Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongsheng Jiang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729464
- Sponsor's protocol ID
- TJ-IRB20221313
- Status last verified
- Feb 2023
- First submitted
- 6 Feb 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If needed, we will share the study protocol, informed consent form and clinical study report.
Publications
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.
PubMed 32033438Lloyd 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.
PubMed 29680102Mahajan 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.
PubMed 31041801Mulder 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.
PubMed 33171494Fernandes 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.
PubMed 30918022Riondino 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.
PubMed 30650562Kim 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.
PubMed 32645431Hisada 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.
PubMed 28807983Khorana 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.
PubMed 18216292Key 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.
PubMed 31381464Mulder 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.
PubMed 30606788
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Prediction Model of Cancer-associated Venous Thromboembolism
- ClinicalTrials.gov ID
- NCT05729464
- Acronym / sponsor ID
- TJ-IRB20221313
- Conditions
- Venous Thromboses, Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Yongsheng JiangUniversity, hospital or other
- Study start
- 23 Dec 2022 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cancer patients with venous thrombosis | – | – |
| cancer patients without venous thrombosis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with malignant tumors in Tongji Hospital in Wuhan.
Key inclusion criteria (1 listed)
- with a histological diagnosis of cancer.
Key exclusion criteria (3 listed)
- received long-term anticoagulant therapy;
- without a clear primary site of malignancy;
- had a follow-up of fewer than 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cancer-associated venous thrombosis
Time frame: 12 months since receiving anti-cancer therapy
including deep venous thrombosis and pulmonary embolism
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Background: PubMed 32033438Mulder 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.
- Background: PubMed 29680102Lloyd 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.
- Background: PubMed 31041801Mahajan 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.
- Background: PubMed 33171494Mulder 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.
- Background: PubMed 30918022Fernandes 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.
- Background: PubMed 30650562Riondino 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.
- Background: PubMed 32645431Kim 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.
- Background: PubMed 28807983Hisada 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.
- Background: PubMed 18216292Khorana 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.
- Background: PubMed 31381464Key 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.
- Background: PubMed 30606788Mulder 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.
- Individual participant dataSharing planned: Undecided. If needed, we will share the study protocol, informed consent form and clinical study report.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboses and Neoplasms, run by Yongsheng Jiang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongsheng Jiang, doctor (027-83662356, ysjiang.china@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cancer-associated venous thrombosis (time frame: 12 months since receiving anti-cancer therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05729464, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.