How gene changes relate to clotting risk in advanced or metastatic non-small-cell lung cancer
Effects of Genomic Profiles on Thromboembolic Risk in Patients With Locally Advanced or Metastatic Non-small-cell Lung Cancer
This project will test whether specific cancer gene changes are linked to blood-clotting markers and the risk of venous blood clots in people with advanced non-small-cell lung cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Of Perugia Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Perugia, Perugia) |
| Trial ID | NCT07288632 on ClinicalTrials.gov |
What this trial studies
This is a multicenter prospective observational study enrolling 500 patients with locally advanced or metastatic NSCLC at 15 Italian oncology centers, with equal groups of oncogene‑addicted and wild‑type tumors. Blood samples will be collected before starting a new anticancer treatment and again at 3 and 6 months to measure plasma tissue factor, thrombin generation, IL‑6, von Willebrand factor, ADAMTS‑13 activity, PAI‑1, and soluble P‑selectin. The study will compare these biomarker levels across oncogene profiles and disease stages and correlate them with clinically overt venous thromboembolism events. Analyses will also examine how anticancer treatments and combined clinical/genomic/biomarker models relate to VTE risk and patient survival.
Who should consider this trial
Good fit: Adults (18+) with cytologically or histologically confirmed locally advanced or metastatic NSCLC who are about to start a new systemic anticancer therapy and have had oncogene testing performed are ideal candidates.
Not a fit: People with recent surgery or radiotherapy, recent chemotherapy, active or prior VTE after cancer diagnosis, ongoing anticoagulation, very poor performance status, or life expectancy under three months are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, results could help identify NSCLC patients at higher risk for blood clots so clinicians can target monitoring or prevention more effectively.
How similar studies have performed: Previous observational work has linked cancer and coagulation biomarkers to VTE risk, but direct associations between specific oncogene mutations and these coagulation markers remain relatively novel and not yet well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Perugia, Perugia
- Emily Oliovecchio — Perugia, Perugia, Italy (Recruiting)
Study contacts
- Principal investigator: Melina Verso — Univesity of Perugia
- Study coordinator: Melina Verso, Professor
- Email: melina.verso@unipg.it
- Phone: 0039+0755782326
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.