Prediction of Venous Thrombosis During chemotherapy-the PINPOINT Study
NCT ID: NCT07196020
Last Updated: 2025-09-29
Study Results
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Basic Information
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NOT_YET_RECRUITING
380 participants
OBSERVATIONAL
2025-10-01
2029-09-01
Brief Summary
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Detailed Description
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VTE is the leading cause of death in cancer patients after the cancer itself. Amongst solid tumours, pancreatic, lung, brain, stomach, and ovarian cancer are the most prothrombotic and are associated with high rates of VTE depending on tumour histology and treatment. The recommended tool for VTE risk assessment during chemotherapy is the Khorana risk score, which was designed to identify ambulatory cancer patients at increased risk of VTE during chemotherapy. This tool has been recommended for use in guiding thromboprophylaxis in cancer patients undergoing chemotherapy. However, the Khorana score performs poorly in cancers of a single type, especially cancers at high risk of VTE. Previous studies have used a variety of biomarkers to predict VTE in cancer patients, however prediction was based on one sample and does not account for the dynamic nature of thrombogenesis particularly during chemotherapy. Dynamic risk assessment using serial measurement of biomarkers during therapy has been recommended as a more effective approach to risk assessment. Guidelines have suggested repeated risk assessment using the new Vienna CAT score (a nomogram based on D-dimer levels and tumour site) may improve risk prediction. Preliminary data has shown suggests that three novel biomarkers may be (soluble Thrombomodulin(TM), Thrombin generation assay\[TGA\] and Factor VIIIc (FVIIIc) levels) measured serially may be effective alone or in combination as dynamic predictive biomarkers for VTE during chemotherapy.
Study objective:
The aim of the study is to measure these three biomarkers (TGA, TM and FVIIIc) serially in lung, ovarian, pancreatic and gastric cancer patients undergoing chemotherapy to dynamically assess the ability of these biomarkers to predict VTE.
Study Design:
The study will recruit 380 patients across three centres in Ireland. Blood samples will be taken from each patient at the following stages during chemotherapy treatment.
1. Before chemotherapy treatment
2. after 4 weeks treatment
3. after 3 months treatment
4. at the end of the current cycle of treatment.
Based on clinical data available, the Khorana Risk Score(KRS) calculated at the start of therapy. The Vienna CAT nomogram will be calculated at each sampling point in the study.
Laboratory Biomarker analysis:
All biomarker analysis will take place at the Coagulation Research Laboratory, Dept of Obstetrics and Gynaecology, Trinity St. James Cancer Institute, St. James's Hospital. Dublin IRELAND sTM will be measured using Enzyme Linked Immunosorbent Assay (ELISA) and FVIIIc will be measured using chromogenic substrate assay . TGA will be measured using fluorimetric assay. D-dimer (for calculation of the Vienna CAT score) will be measured using a 2-step procedure.
All VTE events which occur from baseline to within 3 months of the final sample will be recorded.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cancer patients undergoing chemotherapy
Lung, ovarian and pancreatic cancer patients undergoing chemotherapy.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients who are over 18 years of age
* Patients who are able to give full and informed written consent
Exclusion Criteria
* Any history of significant haemorrhage (requiring hospitalization or transfusion) outside of a surgical setting within the last 5 years
* Familial bleeding diathesis
* Known diagnosis of disseminated intravascular coagulation.
* Surgery within 2 weeks of first baseline sample (with the exception of porth-a-cath implantation or biopsy)
* Chemotherapy or immunotherapy 4 weeks before first baseline sample
* Currently receiving long term anticoagulant therapy (Low Molecular Weight Heparin(LMWH), Direct Oral Anticoagulants(DOACs), Warfarin). Patients receiving aspirin, ticlopidine, clopidogrel or LMWH at a prophylactic dosage for a short period (ie post cancer surgery or during short hospital stay) will be included provided they have completed thromboprophylaxis therapy at the first blood sampling time point.
18 Years
ALL
No
Sponsors
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Cork University Hospital
OTHER
Mater Misericordiae University Hospital
OTHER
University of Dublin, Trinity College
OTHER
Responsible Party
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Lucy Norris
Principal Investigator/Research Fellow
Principal Investigators
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Lucy A Norris, PhD
Role: PRINCIPAL_INVESTIGATOR
Trinity College Dublin (The University of Dublin, Ireland)
Locations
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Cork University Hospital
Cork, , Ireland
Mater Misericordiae University Hospital
Dublin, , Ireland
Trinity Cancer St. James Cancer Institute
Dublin, , Ireland
Countries
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Central Contacts
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Facility Contacts
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References
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Ward MP, Ibrahim EM, O'Toole SA, Marchocki Z, O'Leary JJ, Saadeh FA, Norris LA. Chemotherapy alters thrombomodulin and factor VIIIc expression resulting in acquired activated protein C resistance and enhanced thrombin generation in cancer associated thrombosis. Thromb Res. 2025 Feb;246:109251. doi: 10.1016/j.thromres.2024.109251. Epub 2024 Dec 30.
Pabinger I, van Es N, Heinze G, Posch F, Riedl J, Reitter EM, Di Nisio M, Cesarman-Maus G, Kraaijpoel N, Zielinski CC, Buller HR, Ay C. A clinical prediction model for cancer-associated venous thromboembolism: a development and validation study in two independent prospective cohorts. Lancet Haematol. 2018 Jul;5(7):e289-e298. doi: 10.1016/S2352-3026(18)30063-2. Epub 2018 Jun 7.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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ILP-POR-2024-029
Identifier Type: -
Identifier Source: org_study_id
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