An observational study in Venous Thromboembolism and Cancer, sponsored by University of Dublin, Trinity College. Recruiting at 3 sites in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by University of Dublin, Trinity College · Observational
Cancer patients are at higher risk of getting a blood clot (known as venous thromboembolism (VTE)) especially during chemotherapy and some patients are more at risk than others. These clots can be prevented by using blood thinners (known as anticoagulants) but these are not suitable for everyone as they also carry a risk of bleeding. This study aims to identify which chemotherapy patients are most at risk of a blood clot and at what point in their treatment this is likely to happen. In this project biomarkers in the blood that are involved in blood clotting will be measured in cancer patients at four stages during chemotherapy to see how the biomarkers change during treatment. The blood samples for these tests are taken at the same time as the normal routine blood tests done before a chemotherapy cycle. Biomarker levels will be compared between those patients who subsequently get a VTE and those who do not get a VTE. This will help develop a biomarker based blood test to predict clots during chemotherapy. The biomarker based test will also be compared with other methods of predicting VTE in cancer patients which are currently in use. In the future, this blood test might be used to see if patients are at high risk of a clot during chemotherapy and provide a method to optimise the use of preventative anticoagulants in cancer patients during chemotherapy.
Background:
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.
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.
712 studies on the registry are indexed under Venous Thromboembolism; 146 are open to participants now.
This study's planned enrollment of 380 is below the median of 700 across 282 observational studies indexed under Venous Thromboembolism.
Browse Venous Thromboembolism studies →University of Dublin, Trinity College is the lead sponsor of 73 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with a diagnosis of ovarian, lung, gastric or pancreatic cancer who are scheduled to undergo a course of chemotherapy in the three study centres in Ireland.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lung, ovarian and pancreatic cancer patients undergoing chemotherapy.
Venous thromboembolism
Venous thromboembolism during the chemotherapy
Time frame: From initiation of treatment to 12 weeks from last sample time point
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Limitations according to GDPR regulations in Ireland on what can or cannot be shared
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University of Dublin, Trinity College