A Prospective, Observational Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Solid Tumor
- Sponsor
- Centro di Riferimento Oncologico - Aviano
- Enrollment
- 782
- Locations
- 1
- Primary Endpoint
- Real world prevalence of clinically useful mutations in solid tumors
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients eligible for inclusion in this study have to meet all of the following criteria:
- •Patients, 18 years of age or older
- •Competent and able to comprehend, sign and date an Ethics Committee (EC) approved Informed Consent Form (ICF) before performance of any study-specific procedures or tests
- •Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- •Histologically proven diagnosis solid tumor
- •Diagnosis of advanced or locally advanced disease
- •Patients candidated to receive standard therapy in the following line:
- •first, second or third-line therapy for colon-rectal cancer in IV stage
- •first or second-line therapy for gastric cancer in IV stage
- •primary intent or first-line therapy for pancreatic cancer
Exclusion Criteria
- •Diagnosis of any secondary malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
- •Patients unable or unwilling to undergo as per protocol assessments at the four planned timepoints
Outcomes
Primary Outcomes
Real world prevalence of clinically useful mutations in solid tumors
Time Frame: at the beginning of treatment
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.
Secondary Outcomes
- To identify emerging gene alterations associated with Progression Free Survival(from study enrollment until progression or death for any cause, up to 7 years)
- To evaluate the association between somatic genetic alterations and pattern of metastasis(up to 7 years)
- To evaluate the association between somatic genetic alterations and the histopathological features of the tumor(up to 7 years)
- To evaluate the association between somatic genetic alterations and the clinical characteristic of the enrolled patients(up to 7 years)
- To identify emerging gene alterations associated with Overall Survival(from study enrollment until death for any cause, up to 7 years)
- To describe changes in ctDNA associated biomarkers during treatment(up to 7 years)