A Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)
POPCORN
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)
1 other identifier
observational
782
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 26, 2023
CompletedFirst Submitted
Initial submission to the registry
August 3, 2023
CompletedFirst Posted
Study publicly available on registry
September 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2030
September 13, 2023
August 1, 2023
7 years
August 3, 2023
September 8, 2023
Conditions
Outcome Measures
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.
at the beginning of treatment
Secondary Outcomes (6)
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 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
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 pattern of metastasis
up to 7 years
- +1 more secondary outcomes
Eligibility Criteria
Patients who are receiving therapy for advanced and locally advanced solid tumor as specified in eligibility criteria
You may qualify if:
- 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
- +2 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS, Centro di Riferimento Oncologico (CRO) di Aviano
Aviano, Pordonone, 33081, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fabio Puglisi, MD, PhD
IRCCS-Centro di Riferimento Oncologico (CRO), Aviano (PN)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2023
First Posted
September 8, 2023
Study Start
May 26, 2023
Primary Completion (Estimated)
May 31, 2030
Study Completion (Estimated)
May 31, 2030
Last Updated
September 13, 2023
Record last verified: 2023-08