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

NCT ID: NCT06028724

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 782 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-26
• Study Completion Date: 2030-05-31

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.

Conditions

Solid Tumor; Advanced Solid Tumor; Locally Advanced Solid Tumor; Colon Rectal Cancer; Gastric Cancer; Pancreatic Cancer; Bile Duct Cancer; Hepatocarcinoma; Breast Cancer; Ovarian Cancer; Endometrial Cancer; Cervical Cancer; Vulva Cancer; Melanoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro di Riferimento Oncologico - Aviano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabio Puglisi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS-Centro di Riferimento Oncologico (CRO), Aviano (PN)

Locations

IRCCS, Centro di Riferimento Oncologico (CRO) di Aviano

Aviano, Pordonone, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Fabio Puglisi, MD, PhD

Role: CONTACT

fabio.puglisi@cro.it

0434659253

Giulia Cudia, MSc

Role: CONTACT

giulia.cudia@cro.it

Facility Contacts

Fabio Puglisi, MD, PhD

Role: primary

Other Identifiers

CRO-2022-51

Identifier Type: -

Identifier Source: org_study_id