Clinical trial NCT06028724: A Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Centro di Riferimento Oncologico - Aviano
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 782
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are receiving therapy for advanced and locally advanced solid tumor as specified in eligibility criteria

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.


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

Primary outcomes:
measure: Real world prevalence of clinically useful mutations in solid tumors
timeFrame: at the beginning of treatment
Secondary outcomes:
measure: To identify emerging gene alterations associated with Progression Free Survival
timeFrame: from study enrollment until progression or death for any cause, up to 7 years
measure: To identify emerging gene alterations associated with Overall Survival
timeFrame: from study enrollment until death for any cause, up to 7 years
measure: To describe changes in ctDNA associated biomarkers during treatment
timeFrame: up to 7 years
measure: To evaluate the association between somatic genetic alterations and the histopathological features of the tumor
timeFrame: up to 7 years
measure: To evaluate the association between somatic genetic alterations and pattern of metastasis
timeFrame: up to 7 years
measure: To evaluate the association between somatic genetic alterations and the clinical characteristic of the enrolled patients
timeFrame: up to 7 years
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: IRCCS, Centro di Riferimento Oncologico (CRO) di Aviano
state: Pordonone
Study officials:
affiliation: IRCCS-Centro di Riferimento Oncologico (CRO), Aviano (PN)
name: Fabio Puglisi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: