NCT07196020 Prediction of Venous Thrombosis During chemotherapy-the PINPOINT Study
| NCT ID | NCT07196020 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Dublin, Trinity College |
| Condition | Venous Thromboembolism |
| Study Type | OBSERVATIONAL |
| Enrollment | 380 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2029-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 380 participants in total. It began in 2025-10-01 with a primary completion date of 2029-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Contact & Investigator
Lucy A Norris, PhD
PRINCIPAL INVESTIGATOR
Trinity College Dublin (The University of Dublin, Ireland)
Frequently Asked Questions
Who can join the NCT07196020 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Venous Thromboembolism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07196020 currently recruiting?
Yes, NCT07196020 is actively recruiting participants. Contact the research team at lnorris@tcd.ie for enrollment information.
Where is the NCT07196020 trial being conducted?
This trial is being conducted at Cork, Ireland, Dublin, Ireland, Dublin, Ireland.
Who is sponsoring the NCT07196020 clinical trial?
NCT07196020 is sponsored by University of Dublin, Trinity College. The principal investigator is Lucy A Norris, PhD at Trinity College Dublin (The University of Dublin, Ireland). The trial plans to enroll 380 participants.