Predicting Blood Clots in Cancer Patients on Chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows cancer patients undergoing chemotherapy to see if changes in specific blood biomarkers related to clotting can forecast VTE events. Biomarkers are measured at four points during treatment, aligned with routine blood tests. Researchers compare biomarker patterns between patients who develop VTE and those who do not, with the aim of creating a dynamic, blood-test-based risk predictor to guide preventive strategies.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cork University Hospital
  Cork, Ireland, Ireland Recruiting
• Mater Misericordiae University Hospital
  Dublin, Ireland, Ireland Recruiting
• Trinity Cancer St. James Cancer Institute
  Dublin, Ireland, Ireland Recruiting

Study contacts

• Principal investigator: Lucy A Norris, PhD — Trinity College Dublin (The University of Dublin, Ireland)
• Study coordinator: Lucy A Norris, PhD
• Email: lnorris@tcd.ie
• Phone: 353-1-8972728

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.