Actively Recruiting
Effects of Genomic Profiles on Thromboembolic Risk in Patients With Locally Advanced or Metastatic Non-small-cell Lung Cancer
Led by University Of Perugia · Updated on 2025-12-17
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the link between genetic mutations and blood clot risks in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). This observational study focuses on patients with or without specific oncogene mutations, such as EGFR, KRAS, ALK, ROS1, and PD-1/PD-L1, to understand how these mutations relate to blood clotting factors and venous thromboembolism (VTE) events. The study aims to improve risk assessment tools for clotting complications in NSCLC. Patients diagnosed with NSCLC will be grouped based on the presence or absence of certain gene mutations. Blood samples will be collected before starting anticancer therapy, then again at 3 and 6 months, to measure clotting-related plasma factors like tissue factor, thrombin generation, and inflammatory markers. The study includes follow-up visits at enrollment, 3 months, and 6 months, or earlier if symptoms suggest a clotting event. During the study, participants will undergo blood testing and clinical evaluations to monitor clotting activity and detect any venous thromboembolism. Data collected will include cancer stage, genetic profiles, clotting factor levels, and recorded VTE events. Researchers will analyze these factors to understand clot risks and survival outcomes over a 6-month follow-up or until death, loss to follow-up, or withdrawal.
CONDITIONS
Brief Title
Effects of Genomic Profiles on Thromboembolic Risk in Patients With Locally Advanced or Metastatic Non-small-cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Cytological or histological confirmation of NSCLC
- Locally advanced or metastatic disease (Stage III-IV)
- Starting a new anticancer treatment for locally advanced/metastatic disease (first or further line)
- Testing for oncogenic profile (EGFR, KRAS, ALK, ROS1, PD-1/PD-L1) performed
- Written informed consent
You will not qualify if you...
- Surgery or radiotherapy for lung cancer within the past 3 months before recruitment
- Chemotherapy within the past 1 month before recruitment
- History of venous thromboembolism (VTE) after cancer diagnosis or evidence of VTE at enrollment
- Continuous use of anticoagulant drugs for any reason
- ECOG performance status 3 or 4
- Life expectancy less than 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants are monitored with blood samples collected before starting anticancer therapy, at 3 months, and at 6 months to measure various plasma markers and observe thromboembolic events. Additional visits occur if there is clinical suspicion of a thromboembolic event.
Visits at enrollment, 3 months, and 6 months, with additional visits if symptoms occur
Trial Site Locations
Total: 1 location
1
Emily Oliovecchio
Perugia, Perugia, Italy, 06135
Actively Recruiting
Research Team
M
Melina Verso, Professor
E
Emily Oliovecchio, doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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