Venous ThromboembolismPINPOINTNCT07196020
Prediction of Venous Thrombosis During chemotherapy-the PINPOINT Study
An observational study of Venous Thromboembolism and Cancer, run by University of Dublin, Trinity College at 3 sites in Ireland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Cancer
- How many people
- 380 participants
- Where
- 3 sitesIreland
- Study dates
- 1 Oct 2025to 1 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 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.
Who may be able to join
- Patients with a diagnosis of ovarian, lung, gastric or pancreatic cancer scheduled to undergo a course of chemotherapy who are undergoing adjuvant or neoadjuvant chemotherapy, or who are undergoing chemotherapy for relapsed disease or patients receiving targeted therapy in combination with chemotherapy
- Patients who are over 18 years of age
- Patients who are able to give full and informed written consent
Who cannot join
- Prior history of a documented VTE event within the last 5 years (excluding central line associated events whereby patients completed anticoagulation > 3 months previously)
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland3 sites, 3 recruiting
- Recruiting
Cork University Hospital
Cork, Ireland, T12 DC4A
Dearbhaile Collins, MB Bch PhD, 353-21-4922000, dearbhaile.collins@hse.ie
Erin Crowley, PhD MPSI, 353 86 1284549, erin.crowley@ucc.ie
- Recruiting
Mater Misericordiae University Hospital
Dublin, Ireland, D07R2WY
Barry Kevane, MB Bch PhD, 353-1-8032000, barrykevane@mater.ie
Lisa Scahill, BSc MMEDSci, 353 1 8034831, lscahill@mater.ie
- Recruiting
Trinity Cancer St. James Cancer Institute
Dublin, Ireland, D08W9RT
Lucy A Norris, PhD, 353-1-8962728, lnorris@tcd.ie
Mark P Ward, PhD, 353-1-8961563, wardm6@tcd.ie
About this study
Official title: Prediction and Prevention of Venous Thrombo-embolism(VTE) During Chemotherapy Using Serial Determination of Haemostasis Biomarkers.
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.
Read the detailed description
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.
- Before chemotherapy treatment
- after 4 weeks treatment
- after 3 months treatment
- 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
- Venous Thromboembolism, Cancer
- Keywords
- Chemotherapy, Cancer, Thrombin, Venous thromboembolism, Neoplasms
- Medical subject headings
- Venous Thromboembolism, 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 undergoing chemotherapy | Lung, ovarian and pancreatic cancer patients undergoing chemotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous thromboembolism
Venous thromboembolism during the chemotherapy
Measured: From initiation of treatment to 12 weeks from last sample time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Oct 2025
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- Cork University Hospital, Mater Misericordiae University Hospital
- Responsible party
- Principal investigator, Lucy Norris, University of Dublin, Trinity College
- Investigators
- Lucy A Norris, PhD, Principal investigator, Trinity College Dublin (The University of Dublin, Ireland)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196020
- Sponsor's protocol ID
- ILP-POR-2024-029
- Acronym
- PINPOINT
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Limitations according to GDPR regulations in Ireland on what can or cannot be shared
Publications
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.
PubMed 39793535Pabinger 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.
PubMed 29885940Khorana 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 18216292
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction and Prevention of Venous Thrombo-embolism(VTE) During Chemotherapy Using Serial Determination of Haemostasis Biomarkers.
- ClinicalTrials.gov ID
- NCT07196020
- Acronym / sponsor ID
- PINPOINT / ILP-POR-2024-029
- Conditions
- Venous Thromboembolism, Cancer
- Keywords
- Chemotherapy, Cancer, Thrombin, Venous thromboembolism, Neoplasms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- Cork University Hospital, Mater Misericordiae University Hospital
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 29 Sep 2025 (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.
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.
Detailed description
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.
- Before chemotherapy treatment
- after 4 weeks treatment
- after 3 months treatment
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients undergoing chemotherapy | – | –Lung, ovarian and pancreatic cancer patients undergoing chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Patients with a diagnosis of ovarian, lung, gastric or pancreatic cancer scheduled to undergo a course of chemotherapy who are undergoing adjuvant or neoadjuvant chemotherapy, or who are undergoing chemotherapy for relapsed disease or patients receiving targeted therapy in combination with chemotherapy
- Patients who are over 18 years of age
- Patients who are able to give full and informed written consent
Key exclusion criteria (7 listed)
- Prior history of a documented VTE event within the last 5 years (excluding central line associated events whereby patients completed anticoagulation > 3 months previously)
- 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)
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
Venous thromboembolism
Time frame: From initiation of treatment to 12 weeks from last sample time point
Venous thromboembolism during the chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 39793535Ward 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.
- Background: PubMed 29885940Pabinger 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.
- 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.
- Individual participant dataSharing planned: Undecided. Limitations according to GDPR regulations in Ireland on what can or cannot be shared
Related trials for Venous Thromboembolism
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
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.
Lucy A Norris, PhD principal investigator
Trinity College Dublin (The University of Dublin, Ireland)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism and Cancer, run by University of Dublin, Trinity College at 3 sites in Ireland.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ireland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucy A Norris, PhD (353-1-8972728, lnorris@tcd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous thromboembolism (time frame: From initiation of treatment to 12 weeks from last sample time point). 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 NCT07196020, which also lists 3 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 May 2026.