A Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Gen… (NCT06028724) | Clinical Trial Compass
RecruitingNot Applicable
A Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)
Italy782 participantsStarted 2023-05-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Real world prevalence of clinically useful mutations in solid tumors