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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06028724
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Centro di Riferimento Oncologico - Aviano
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Fabio Puglisi, MD, PhD
Principal Investigator Affiliation	IRCCS-Centro di Riferimento Oncologico (CRO), Aviano (PN)
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	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

Contact a Trial Team

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International Sites

Aviano 3182635, Pordonone, Italy

Status

Recruiting

Address

IRCCS, Centro di Riferimento Oncologico (CRO) di Aviano

Aviano 3182635, Pordonone, 33081

Site Contact

Fabio Puglisi, MD, PhD

[email protected]

0434659253

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