NCT06028724Recruiting
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 · Last updated 13 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 782 (estimated)
- First submitted
- 3 Aug 2023
- Start date
- 26 May 2023
- Primary completion date
- 31 May 2030
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Diseases
- Melanoma, Endometrial cancer, Cervical cancer, Pancreatic cancer, Colorectal cancer, Liver and biliary tract cancer, Gastric and esophageal cancer, Ovarian cancer
- NCT number
- NCT06028724
What you commit to
- Study type: Observational
- Planned participants: 782
- From 26 May 2023 to the primary completion date, 31 May 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Patients unable or unwilling to undergo as per protocol assessments at the four planned timepoints
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS, Centro di Riferimento Oncologico (CRO) di Aviano Coordinator of this site? Confirm its status | Aviano | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.