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Effects of Genomic Profiles on Thromboembolic Risk in Patients With Locally Advanced or Metastatic Non-small-cell Lung Cancer

Recruitingn/aAges 18 Years - anyAllUniversity Of Perugia
NCT07288632 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Multicenter, prospective observational study (15 Oncologic Centers, in Italy). The purpose of the study is to assess the thromboembolic potential in patients with oncogene-addicted and wild-type NSCLC. The primary aim of this project is to evaluate the association between oncogene mutations and levels of plasma parameters of the activated coagulation cascade as the plasma levels of TF, thrombin generation, IL 6, vWF, ADAMTS-13 activity, PAI-1, and soluble P-selectin in NSCLC patients. A total of 500 NSCLC patients with a diagnosis (cytologically or histologically confirmed) of locally advanced or metastatic disease will be enrolled in the study, with a ratio of 1:1 for oncogene addicted or wild-type group. The oncogene-addicted group (Group A): patients with at least one oncogene mutation (i.e., patients expressing EGFR mutations, KRAS mutation, ALK or ROS1 rearrangements); the wild type

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📋 Eligibility rules (as published)
Inclusion Criteria: * • Patients aged 18 years or older, * Cytological or histological confirmation of NSCLC, * Locally advanced or metastatic disease (Stage III-IV), * Patients starting a new anticancer treatment for locally advanced/metastatic disease (first or further line of treatment), * Testing for oncogenic (EGFR, KRAS, ALK, ROS1 and PD-1/PD-L1) profile performed, * Written informed consent Exclusion Criteria: * • Patients received surgery or radiotherapy for lung cancer within the past 3 months before recruitment or chemotherapy within the past 1 months before recruitment, * Patients with a history of VTE after cancer diagnosis or evidence of VTE events at enrollment * Continuative use of anticoagulant drugs for any indication (atrial fibrillation or previous VTE) * ECOG performance profile 3 or 4 * Life expectancy of less than 3 months
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What it tests

  • Not listed
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Where

1 site
Emily Oliovecchio
Perugia, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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