Clinical trial · Observational
A Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Bile Duct Cancer | Malignant Bile Duct Neoplasm | CURATED_BROADER | 0.80 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Colon Rectal Cancer | — | UNRESOLVED | — |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Hepatocarcinoma | — | UNRESOLVED |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Real world prevalence of clinically useful mutations in solid tumors
- timeFrame
- at the beginning of treatment
- description
- 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.
Secondary outcomes (6)
- 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
- description
- To identify emerging gene alterations associated with Progression Free Survival (PFS) defined as the time from study enrollment until progression or death for any cause, whichever comes first
- measure
- To identify emerging gene alterations associated with Overall Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available