Status:
RECRUITING
A Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)
Lead Sponsor:
Centro di Riferimento Oncologico - Aviano
Conditions:
Solid Tumor
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
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 generat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 26 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2030
Estimated Enrollment :
782 Patients enrolled
Trial Details
Trial ID
NCT06028724
Start Date
May 26 2023
End Date
May 31 2030
Last Update
September 13 2023
Active Locations (1)
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1
IRCCS, Centro di Riferimento Oncologico (CRO) di Aviano
Aviano, Pordonone, Italy, 33081