Prediction of Venous Thrombosis During chemotherapy-the PINPOINT Study

NCT07196020 | Not Yet Recruiting

• 1 other identifier: ILP-POR-2024-029
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 3

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.

Conditions

Venous Thromboembolism; Cancer

Keywords

Chemotherapy; Cancer; Thrombin; Venous thromboembolism; Neoplasms

Outcome Measures

Primary Outcomes (1)

• Venous thromboembolism

  Venous thromboembolism during the chemotherapy

  From initiation of treatment to 12 weeks from last sample time point

Study Arms (1)

Cancer patients undergoing chemotherapy

Lung, ovarian and pancreatic cancer patients undergoing chemotherapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Dublin, Trinity College: lead
• Cork University Hospital: collaborator
• Mater Misericordiae University Hospital: collaborator

Study Sites (3)

Cork University Hospital

Cork, T12 DC4A, Ireland

Location

Mater Misericordiae University Hospital

Dublin, D07R2WY, Ireland

Location

Trinity Cancer St. James Cancer Institute

Dublin, D08W9RT, Ireland

Location

Related Publications (3)

• 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.

  PMID: 39793535 BACKGROUND

• 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.

  PMID: 29885940 BACKGROUND

• 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.

  PMID: 18216292 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples (citrated plasma)

MeSH Terms

Conditions

Venous Thromboembolism; Neoplasms

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Lucy A Norris, PhD

  Trinity College Dublin (The University of Dublin, Ireland)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucy A Norris, PhD

CONTACT

353-1-8972728; lnorris@tcd.ie

Mark P Ward, PhD

CONTACT

353-1-8961563; wardm6@tcd.ie

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator/Research Fellow

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 29, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

IE (3)