The PROPHETIC study is a prospective, multi-center, international clinical study aimed at developing an algorithm to predict patient outcomes. The study involves analyzing the proteomic profiles of patients undergoing therapy to assess the likelihood of clinical benefit from their prescribed treatment. Blood samples are collected prior to and during the treatment period and analyzed as part of the ongoing development of thealgorithm.
The goal of this research study is to develop an algorithm that predicts the patient's treatment outcome.This algorithm will serve as a tool for physicians when making treatment decisions, specifically for stage IV NSCLC and malignant melanoma patients receiving anti-cancer treatments. The investigators also aim to identify the metabolic pathways that could lead to better therapeutic options. The patients will be given their treatment according to the institute's standard of care. The patients will provide two blood samples and clinical data will be collected from their medical records. In the first part of the trial, the data obtained from the blood samples and the medical records of the patients will be used to develop the prediction algorithm, and in the second part of the trial, the algorithm will be validated by comparing the objective response rate of the patients to the theoretical response prediction of the algorithm.
Study Type
OBSERVATIONAL
Enrollment
10,000
Collect at least two plasma samples
Birmingham VAHCS
Birmingham, Alabama, United States
Mayo Clinic
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Florida Cancer Specialist and Research Institute
Orlando, Florida, United States
Protean Biodiagnosics
Orlando, Florida, United States
Northwest Community Healthcare
Measured biological features at baseline (pre-treatment) and after 1st dose administration (on-treatment) and during treatment (optional)
Biological features are analyzed in biological samples taken from the patients as part of the study
Time frame: Measured biological features are analyzed in samples taken at baseline (prior treatment) and after the 1st dose administration (on-treatment) and during treatment (optional)
Overall response as determined by RECIST 1.1 or any other validated clinical scales for response, every 3 months or according to the standard of care
Overall response as determined by RECIST 1.1 or any other validated clinical scales for response, every 3 months or according to the standard of care
Time frame: Every 3 months or according to the standard of care
Progression Free Survival (PFS)
Collect Progression Free Survival (PFS) dates
Time frame: At progression during treatment
Overall survival or last follow-up
Collect overall survival or last follow-up dates
Time frame: Overall survival or last follow-up
Adverse Events (AE)
AE to treatment, as reported by the patient
Time frame: Adverse events (AE) during treatment and until the end of study
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Helen Nassif Community Cancer Center
Cedar Rapids, Iowa, United States
Rutgers Cancer Institute
New Brunswick, New Jersey, United States
Roswell Park
Buffalo, New York, United States
West Clinic
Germantown, Tennessee, United States
...and 31 more locations