The implementation of liquid biopsy in clinical practice has been favored by the rapid development of genome sequencing techniques designed to analyze mutations in ctDNA. Among these, the Next generation sequencing (NGS) is a technique that consists in sequencing several genomes in a short time span, collecting information about a wider range of genomic alterations, using small quantities of genetic material. It is used to identify potential circulating dynamic biomarkers of treatment sensitivity or resistance in a real word multi-pathology evaluation. In this way, defining the mutational status of clinical relevance genes in real world, as a predictive biomarker to identify those patients most likely to benefit from target therapy, offers the potential to optimize access to further therapies. The aim of this study is to evaluate the real-world prevalence of clinically useful mutations in patients who are receiving therapy for advanced and locally advanced solid tumor through liquid biopsy.
Study Type
OBSERVATIONAL
Enrollment
782
IRCCS, Centro di Riferimento Oncologico (CRO) di Aviano
Aviano, Pordonone, Italy
RECRUITINGReal world prevalence of clinically useful mutations in solid tumors
Real world prevalence of clinically useful mutations in solid tumors, defined as the proportion of patients with the detection of clinically useful mutations through ctDNA NGS, at the beginning of systemic therapies defined as per inclusion criteria for advanced disease.
Time frame: at the beginning of treatment
To identify emerging gene alterations associated with Progression Free Survival
To identify emerging gene alterations associated with Progression Free Survival (PFS) defined as the time from study enrollment until progression or death for any cause, whichever comes first
Time frame: from study enrollment until progression or death for any cause, up to 7 years
To identify emerging gene alterations associated with Overall Survival
To identify emerging gene alterations associated with Overall Survival, defined as the time from study enrollment until death for any cause
Time frame: from study enrollment until death for any cause, up to 7 years
To describe changes in ctDNA associated biomarkers during treatment
Difference in frequency of patients with ctDNA associated biomarkers at different time point during treatment (at baseline, at start of cycle 2, at first radiological evaluation, at relapse or end of follow-up)
Time frame: up to 7 years
To evaluate the association between somatic genetic alterations and the histopathological features of the tumor
Frequency of somatic genetic alterations in subgroups of patients with different histopathological tumor characteristics
Time frame: up to 7 years
To evaluate the association between somatic genetic alterations and pattern of metastasis
Frequency of somatic genetic alterations in subgroups of patients with metastasis
Time frame: up to 7 years
To evaluate the association between somatic genetic alterations and the clinical characteristic of the enrolled patients
Frequency of somatic genetic alterations in subgroups of patients with different clinical characteristics
Time frame: up to 7 years
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