Effects of Genomic Profiles on Thromboembolic Risk in Patients With Locally Advanced or Metastatic Non-small-cell Lung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Of Perugia
About this trial
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
This trial does not accept healthy volunteersQualifiers
• 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),
Disqualifiers
• 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
Trial population
Patients with diagnosis (cytologically or histologically confirmed) of locally advanced or metastatic disease will be enrolled in the study with a ratio 1:1 for oncogene addicted or wild type group.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 1 trial groupGroup A: patients with diagnosis of locally advanced or metastatic NSCLC
Trial outcomes
Primary outcomes
1
Levels of plasma TF, thrombin generation, IL6, vWF, ADAMTS-13 activity, PAI-1and soluble P-selectin
Levels of plasma TF, thrombin generation, IL6, vWF, ADAMTS-13 activity, PAI-1and soluble P-selectin in patients with NSCLC before the starting of the new line of anticancer therapy and after 3 and 6 months of anticancer treatment, across different patterns and association of oncogene mutations.
Time frame
From enrollment to the end of study period at 6 monthsSponsors and contacts
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Source ClinicalTrials.gov