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

September 8, 2023 updated by: Centro di Riferimento Oncologico - Aviano

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)

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

782

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Fabio Puglisi, MD, PhD
Phone Number: 0434659253
Email: fabio.puglisi@cro.it

Study Contact Backup

Name: Giulia Cudia, MSc
Email: giulia.cudia@cro.it

Study Locations

Italy
- Pordonone
  - Aviano, Pordonone, Italy, 33081
    - Recruiting
    - IRCCS, Centro di Riferimento Oncologico (CRO) di Aviano
    - Contact:
      
      Fabio Puglisi, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

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

Description

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
first-line therapy for bile duct cancer
first or second-line therapy for hepatocarcinoma
first, second, third, fourth or fifth-line therapy for breast cancer in IV stage
chemotherapy for ovarian cancer in advanced stage (FIGO III-IV) and at the time of first relapse
first or second-line therapy for endometrial cancer in advanced stage (FIGO III-IV)
first or second-line therapy for advanced or locally advanced cervical cancer
therapy for locally advanced or first line therapy for metastatic vulva cancer
first, second or third-line therapy for melanoma (third-line therapy only in BRAF-mutated melanoma)

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at the beginning of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To identify emerging gene alterations associated with Progression Free Survival Time Frame: from study enrollment until progression or death for any cause, up to 7 years	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	from study enrollment until progression or death for any cause, up to 7 years
To identify emerging gene alterations associated with Overall Survival Time Frame: from study enrollment until death for any cause, up to 7 years	To identify emerging gene alterations associated with Overall Survival, defined as the time from study enrollment until death for any cause	from study enrollment until death for any cause, up to 7 years
To describe changes in ctDNA associated biomarkers during treatment Time Frame: up to 7 years	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)	up to 7 years
To evaluate the association between somatic genetic alterations and the histopathological features of the tumor Time Frame: up to 7 years	Frequency of somatic genetic alterations in subgroups of patients with different histopathological tumor characteristics	up to 7 years
To evaluate the association between somatic genetic alterations and pattern of metastasis Time Frame: up to 7 years	Frequency of somatic genetic alterations in subgroups of patients with metastasis	up to 7 years
To evaluate the association between somatic genetic alterations and the clinical characteristic of the enrolled patients Time Frame: up to 7 years	Frequency of somatic genetic alterations in subgroups of patients with different clinical characteristics	up to 7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro di Riferimento Oncologico - Aviano

Investigators

Principal Investigator: Fabio Puglisi, MD, PhD, IRCCS-Centro di Riferimento Oncologico (CRO), Aviano (PN)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2023

Primary Completion (Estimated)

May 31, 2030

Study Completion (Estimated)

May 31, 2030

Study Registration Dates

First Submitted

August 3, 2023

First Submitted That Met QC Criteria

September 7, 2023

First Posted (Actual)

September 8, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria