NCT07288632 Effects of Genomic Profiles on Thromboembolic Risk in Patients With Locally Advanced or Metastatic Non-small-cell Lung Cancer
| NCT ID | NCT07288632 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Of Perugia |
| Condition | Venous Thromboembolism (VTE) |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-02-09 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2024-02-09 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 group (Group B): patients without oncogene mutations, categorized in 2 subgroups according to expression of PD1/PD-L1 mutation or not. Patients will be followed up prospectively for 6 months or until death, VTE event, loss to follow-up, or voluntary consent withdrawal. This study will evaluate the effects of EGFR, KRAS mutations and ALK/ROS 1 and PD-1/PD-L1 rearrangements on the expression of TF and thrombin generation or the interaction between inflammation and endothelial or platelet and cancer cells, in patients with NSCLC. The study will also evaluate the potential correlation between VTE events and the expression of oncogene mutations in patients with NSCLC. The results of this study could generate the hypothesis of including the genetic profile as variable for a risk-stratification tools and decision-making algorithms in NSCLC patients.
Eligibility 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
Contact & Investigator
Melina Verso
PRINCIPAL INVESTIGATOR
Univesity of Perugia
Frequently Asked Questions
Who can join the NCT07288632 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Venous Thromboembolism (VTE). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07288632 currently recruiting?
Yes, NCT07288632 is actively recruiting participants. Contact the research team at melina.verso@unipg.it for enrollment information.
Where is the NCT07288632 trial being conducted?
This trial is being conducted at Perugia, Italy.
Who is sponsoring the NCT07288632 clinical trial?
NCT07288632 is sponsored by University Of Perugia. The principal investigator is Melina Verso at Univesity of Perugia. The trial plans to enroll 500 participants.