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

Last updated: October 12, 2025
Sponsor: OncoHost Ltd.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Melanoma

Small Cell Lung Cancer

Treatment

Plasma sample collection

Clinical Study ID

NCT04056247
OH-HRPP-001
  • Ages > 18
  • All Genders

Study 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.

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:

  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 40mL/min

  5. Total bilirubin lower than 1.5 mg/dL, ALT and AST levels ≤ 3 times above theupper 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

Exclusion Criteria:

  • Concurrent and/or other active malignancy that has required systemic treatmentwithin 2 years of first dose of study drug

  • Generalized impairment or mental incompetence that would render the patient unableto understand his/her participation in the study.

Study Design

Total Participants: 10000
Treatment Group(s): 1
Primary Treatment: Plasma sample collection
Phase:
Study Start date:
October 01, 2019
Estimated Completion Date:
October 01, 2029

Study 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.

Connect with a study center

  • Asklepois

    Gauting, 82131
    Germany

    Site Not Available

  • Asklepois

    Gauting 2922230, 82131
    Germany

    Site Not Available

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, 69126
    Germany

    Site Not Available

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg 2907911, 69126
    Germany

    Site Not Available

  • Haemek Medical Center

    Afula,
    Israel

    Site Not Available

  • Haemek Medical Center

    Afula 295740,
    Israel

    Site Not Available

  • Barzilai Medical Center

    Ashkelon,
    Israel

    Site Not Available

  • Barzilai Medical Center

    Ashkelon 295620,
    Israel

    Site Not Available

  • Soroka Medical Center

    Be'er Sheva,
    Israel

    Site Not Available

  • Shamir Medical Center

    Be'er Ya'aqov,
    Israel

    Site Not Available

  • Soroka Medical Center

    Beersheba 295530,
    Israel

    Site Not Available

  • Shamir Medical Center

    Be’er Ya‘aqov 295525,
    Israel

    Site Not Available

  • Bnai Zion Medical Center

    Haifa,
    Israel

    Site Not Available

  • Rambam Medical Center

    Haifa,
    Israel

    Site Not Available

  • Bnai Zion Medical Center

    Haifa 294801,
    Israel

    Site Not Available

  • Rambam Medical Center

    Haifa 294801,
    Israel

    Site Not Available

  • Hadassah Medcial Center

    Jerusalem,
    Israel

    Site Not Available

  • Hadassah Medcial Center

    Jerusalem 281184,
    Israel

    Site Not Available

  • Meir medical center

    Kfar Saba,
    Israel

    Site Not Available

  • Meir medical center

    Kfar Saba 294514,
    Israel

    Site Not Available

  • Rabin Medical Center

    Petah Tikva 293918,
    Israel

    Site Not Available

  • Rabin Medical Center

    Petah tikva,
    Israel

    Site Not Available

  • Kaplan Medical Center

    Rehovot 293725,
    Israel

    Site Not Available

  • Kaplan Medical Center

    Reẖovot,
    Israel

    Site Not Available

  • Assuta Medical Cetner

    Tel Aviv,
    Israel

    Site Not Available

  • Sheba Medical Center

    Tel Aviv,
    Israel

    Active - Recruiting

  • Sourasky Medical Center

    Tel Aviv,
    Israel

    Completed

  • Assuta Medical Cetner

    Tel Aviv 293397,
    Israel

    Site Not Available

  • Sheba Medical Center

    Tel Aviv 293397,
    Israel

    Site Not Available

  • Sourasky Medical Center

    Tel Aviv 293397,
    Israel

    Site Not Available

  • Sheba medical center

    Tel HaShomer,
    Israel

    Site Not Available

  • Sheba medical center

    Tel Litwinsky 293361,
    Israel

    Site Not Available

  • 044 Hospital Universitario Virgen Macarena

    Seville,
    Spain

    Site Not Available

  • 044 Hospital Universitario Virgen Macarena

    Seville 2510911,
    Spain

    Site Not Available

  • Aberdeen Royal Infirmary

    Aberdeen,
    United Kingdom

    Site Not Available

  • Aberdeen Royal Infirmary

    Aberdeen 2657832,
    United Kingdom

    Site Not Available

  • Royal Bournemouth General Hospital

    Bournemouth,
    United Kingdom

    Site Not Available

  • Royal Bournemouth General Hospital

    Bournemouth 2655095,
    United Kingdom

    Site Not Available

  • Bradford Teaching Hospitals

    Bradford, BD9 6RJ
    United Kingdom

    Site Not Available

  • Bradford Teaching Hospitals

    Bradford 2654993, BD9 6RJ
    United Kingdom

    Site Not Available

  • Cheltenham General Hospital

    Cheltenham,
    United Kingdom

    Site Not Available

  • Cheltenham General Hospital

    Cheltenham 2653261,
    United Kingdom

    Site Not Available

  • Withybush Hospital

    Haverfordwest, SA61 2PZ
    United Kingdom

    Site Not Available

  • Withybush Hospital

    Haverfordwest 2647311, SA61 2PZ
    United Kingdom

    Site Not Available

  • Mount Vernon Cancer Centre

    Northwood,
    United Kingdom

    Site Not Available

  • Mount Vernon Cancer Centre

    Northwood 2641216,
    United Kingdom

    Site Not Available

  • The Shrewsbury and Telford Hospital

    Shrewsbury,
    United Kingdom

    Site Not Available

  • The Shrewsbury and Telford Hospital

    Shrewsbury 2637891,
    United Kingdom

    Site Not Available

  • South Tyneside

    South Shields, NE34 0PL
    United Kingdom

    Site Not Available

  • South Tyneside

    South Shields 2637329, NE34 0PL
    United Kingdom

    Site Not Available

  • Lister Hospital

    Stevenage,
    United Kingdom

    Site Not Available

  • Lister Hospital

    Stevenage 2636940,
    United Kingdom

    Site Not Available

  • Sunderland Royal Hospital

    Sunderland, SR4 7TP
    United Kingdom

    Site Not Available

  • Sunderland Royal Hospital

    Sunderland 2636531, SR4 7TP
    United Kingdom

    Site Not Available

  • Swansea Bay UHB Singleton Hospital

    Swansea,
    United Kingdom

    Site Not Available

  • Swansea Bay UHB Singleton Hospital

    Swansea 2636432,
    United Kingdom

    Site Not Available

  • Torbay Hospital

    Torquay,
    United Kingdom

    Site Not Available

  • Torbay Hospital

    Torquay 2635650,
    United Kingdom

    Site Not Available

  • Birmingham VAHCS

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Birmingham VAHCS

    Birmingham 4049979, Alabama 4829764 35233
    United States

    Site Not Available

  • Mayo Clinic

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Florida Cancer Specialist and Research Institute

    Orlando, Florida 32827
    United States

    Site Not Available

  • Protean Biodiagnosics

    Orlando, Florida 32827
    United States

    Active - Recruiting

  • Mayo Clinic

    Jacksonville 4160021, Florida 4155751 32224
    United States

    Site Not Available

  • University of Miami

    Miami 4164138, Florida 4155751 33136
    United States

    Site Not Available

  • Florida Cancer Specialist and Research Institute

    Orlando 4167147, Florida 4155751 32827
    United States

    Site Not Available

  • Protean Biodiagnosics

    Orlando 4167147, Florida 4155751 32827
    United States

    Site Not Available

  • Northwest Community Healthcare

    Rolling Meadows, Illinois 60008
    United States

    Site Not Available

  • Northwest Community Healthcare

    Rolling Meadows 4908052, Illinois 4896861 60008
    United States

    Site Not Available

  • Helen Nassif Community Cancer Center

    Cedar Rapids, Iowa 52403
    United States

    Site Not Available

  • Helen Nassif Community Cancer Center

    Cedar Rapids 4850751, Iowa 4862182 52403
    United States

    Site Not Available

  • Rutgers Cancer Institute

    New Brunswick, New Jersey 08903
    United States

    Site Not Available

  • Rutgers Cancer Institute

    New Brunswick 5101717, New Jersey 5101760 08903
    United States

    Site Not Available

  • Roswell Park

    Buffalo, New York 14263
    United States

    Site Not Available

  • Roswell Park

    Buffalo 5110629, New York 5128638 14263
    United States

    Site Not Available

  • West Clinic

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • West Clinic

    Germantown 4624601, Tennessee 4662168 38138
    United States

    Site Not Available

  • Michael E. Debakey VA Medical Center

    Houston, Texas 77030
    United States

    Site Not Available

  • 151-Christus Health St. Michael

    Texarkana, Texas 75503
    United States

    Site Not Available

  • Michael E. Debakey VA Medical Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • 151-Christus Health St. Michael

    Texarkana 4736096, Texas 4736286 75503
    United States

    Site Not Available

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