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

Recruiting
18 years of age
Both
Phase N/A

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Overview

This study will develop an algorithm of identifying patients with stage IV NSCLC and Melanoma who could benefit from cancer treatment they receive.

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.

Eligibility

Inclusion Criteria:

  • Cancer patients with stage IV NSCLC or stage IV malignant melanoma
  • Patient must have at least one measurable lesion and the relevant images in order to enable assessment of response
  • ECOG PS - 0/1-2
  • Normal hematologic, renal and liver function:
    1. Absolute neutrophil count higher than 1500/mm3
    2. Platelets count higher than 100,000/mm3
    3. haemoglobin higher than 9 g/dL
    4. Creatinine concentration ≤1.4 mg/dL, or creatinine clearance higher than 40 mL/min
    5. Total bilirubin lower than 1.5 mg/dL, ALT and AST levels ≤ 3 times above the upper normal limit.

Exclusion Criteria:

  • Concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug
  • Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study.

Study details

Stage IV Non-small Cell Lung Cancer, Stage IV Malignant Melanoma, Stage IV Small Cell Lung Cancer, Stage III Malignant Melanoma

NCT04056247

OncoHost Ltd.

26 January 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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