NCT04056247

Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments

PROPHETIC - Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: OncoHost Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Stage IV Non-small Cell Lung Cancer
• Stage IV Malignant Melanoma
• Stage IV Small Cell Lung Cancer
• Stage III Unresectable Non-Small Cell Lung Cancer
• Stage IIIb-d Malignant Melanoma

Interventions

Type	Name	Description
OTHER	Plasma sample collection	Collect at least two plasma samples

Timeline

• Start date: 2019-10-01
• Primary completion: 2029-10-01
• Completion: 2029-10-01
• First posted: 2019-08-14
• Last updated: 2025-10-15

Locations

41 sites across 5 countries: United States, Germany, Israel, Spain, United Kingdom