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

Launched by CENTRO DI RIFERIMENTO ONCOLOGICO - AVIANO · Sep 7, 2023

Keywords

ClinConnect Summary

The POPCORN trial is studying how common certain genetic changes, known as mutations, are in patients with advanced solid tumors, like colon, gastric, pancreatic, breast, and several others. This research uses a method called liquid biopsy, which involves analyzing a simple blood sample to find these mutations. By identifying these genetic changes, doctors hope to better understand which patients might respond well to specific treatments, potentially improving their chances of receiving effective therapy.

To participate in this study, individuals must be at least 18 years old and have a confirmed diagnosis of an advanced solid tumor. They should be receiving or planning to receive standard treatment for their condition. Participants will need to agree to follow the study's schedule, which includes visits and tests. Overall, this trial aims to gather valuable information that could help tailor cancer treatment based on each patient's unique genetic profile.

Gender

ALL

Eligibility 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