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Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

OncoHost Ltd.

Conditions:

Stage IV Non-small Cell Lung Cancer

Stage IV Malignant Melanoma

Eligibility:

All Genders

18+ years

Brief 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 pa...

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, specificall...

Eligibility Criteria

Inclusion

  • Inclusion criteria
  • Provision of informed consent prior to any study-specific procedures.
  • Male or female aged at least 18 years.
  • ECOG PS - 0/1-2
  • Normal hematologic, renal and liver function:
  • Absolute neutrophil count higher than 1500/mm3
  • Platelets count higher than 100,000/mm3
  • haemoglobin higher than 9 g/dL
  • Creatinine concentration ≤1.4 mg/dL, or creatinine clearance higher than 40 mL/min
  • Total bilirubin lower than 1.5 mg/dL, ALT and AST levels ≤ 3 times above the upper normal limit.
  • At least one measurable lesion in order to enable the assessment of the response (except for stage IIIb-d malignant melanoma patients).
  • 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.

Exclusion

    Key Trial Info

    Start Date :

    October 1 2019

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    October 1 2029

    Estimated Enrollment :

    10000 Patients enrolled

    Trial Details

    Trial ID

    NCT04056247

    Start Date

    October 1 2019

    End Date

    October 1 2029

    Last Update

    October 15 2025

    Active Locations (41)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 11 (41 locations)

    1

    Birmingham VAHCS

    Birmingham, Alabama, United States, 35233

    2

    Mayo Clinic

    Jacksonville, Florida, United States, 32224

    3

    University of Miami

    Miami, Florida, United States, 33136

    4

    Florida Cancer Specialist and Research Institute

    Orlando, Florida, United States, 32827