Actively Recruiting
A Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)
Led by Centro di Riferimento Oncologico - Aviano · Updated on 2023-09-13
782
Participants Needed
1
Research Sites
366 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older
- Able to understand, sign, and date informed consent
- Willing and able to follow scheduled visits, treatment plans, lab tests, and study procedures
- Histologically confirmed diagnosis of solid tumor
- Diagnosed with advanced or locally advanced disease
- Candidates for standard therapy as follows:
- First, second, or third-line therapy for stage IV colon-rectal cancer
- First or second-line therapy for stage IV gastric cancer
- Primary intent or first-line therapy for pancreatic cancer
- First-line therapy for bile duct cancer
- First or second-line therapy for hepatocarcinoma
- First through fifth-line therapy for stage IV breast cancer
- Chemotherapy for advanced ovarian cancer (FIGO III-IV) at first relapse
- First or second-line therapy for advanced endometrial cancer (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 only if BRAF-mutated)
You will not qualify if you...
- Diagnosis of any secondary malignancy within the last 3 years, except treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- Unable or unwilling to undergo protocol assessments at the four planned timepoints
AI-Screening
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Trial Site Locations
Total: 1 location
1
IRCCS, Centro di Riferimento Oncologico (CRO) di Aviano
Aviano, Pordonone, Italy, 33081
Actively Recruiting
Research Team
F
Fabio Puglisi, MD, PhD
CONTACT
G
Giulia Cudia, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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