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A Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)

ConditionsSolid TumorAdvanced Solid TumorLocally Advanced Solid TumorColon Rectal CancerGastric CancerPancreatic CancerBile Duct CancerHepatocarcinomaBreast CancerOvarian CancerEndometrial CancerCervical CancerVulva CancerMelanoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentro di Riferimento Oncologico - Aviano

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients who are receiving therapy for advanced and locally advanced solid tumor as specified in eligibility criteria

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Real 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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centro di Riferimento Oncologico - Aviano

Lead sponsor

Source ClinicalTrials.gov
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