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

Last updated: August 25, 2023
Sponsor: OncoHost Ltd.
Overall Status: Active - 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

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

Eligibility Criteria

Inclusion

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 toenable 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 40mL/min
  5. Total bilirubin lower than 1.5 mg/dL, ALT and AST levels ≤ 3 times above theupper normal limit.

Exclusion

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 tounderstand his/her participation in the study.

Study Design

Total Participants: 2000
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

    Active - Recruiting

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, 69126
    Germany

    Active - Recruiting

  • Haemek Medical Center

    Afula,
    Israel

    Active - Recruiting

  • Barzilai Medical Center

    Ashkelon,
    Israel

    Active - Recruiting

  • Soroka Medical Center

    Be'er Sheva,
    Israel

    Site Not Available

  • Shamir Medical Center

    Be'er Ya'aqov,
    Israel

    Active - Recruiting

  • Bnai Zion Medical Center

    Haifa,
    Israel

    Site Not Available

  • Rambam Medical Center

    Haifa,
    Israel

    Active - Recruiting

  • Hadassah Medcial Center

    Jerusalem,
    Israel

    Active - Recruiting

  • Meir medical center

    Kfar Saba,
    Israel

    Active - Recruiting

  • Rabin Medical Center

    Petah tikva,
    Israel

    Active - Recruiting

  • Kaplan Medical Center

    Reẖovot,
    Israel

    Active - Recruiting

  • Assuta Medical Cetner

    Tel Aviv,
    Israel

    Active - Recruiting

  • Sheba Medical Center

    Tel Aviv,
    Israel

    Active - Recruiting

  • Sourasky Medical Center

    Tel Aviv,
    Israel

    Completed

  • Sheba medical center

    Tel HaShomer,
    Israel

    Active - Recruiting

  • 044 Hospital Universitario Virgen Macarena

    Seville,
    Spain

    Active - Recruiting

  • Aberdeen Royal Infirmary

    Aberdeen,
    United Kingdom

    Active - Recruiting

  • Royal Bournemouth General Hospital

    Bournemouth,
    United Kingdom

    Active - Recruiting

  • Bradford Teaching Hospitals

    Bradford, BD9 6RJ
    United Kingdom

    Site Not Available

  • Cheltenham General Hospital

    Cheltenham,
    United Kingdom

    Active - Recruiting

  • Withybush Hospital

    Haverfordwest, SA61 2PZ
    United Kingdom

    Active - Recruiting

  • Mount Vernon Cancer Centre

    Northwood,
    United Kingdom

    Active - Recruiting

  • The Shrewsbury and Telford Hospital

    Shrewsbury,
    United Kingdom

    Active - Recruiting

  • South Tyneside

    South Shields, NE34 0PL
    United Kingdom

    Active - Recruiting

  • Lister Hospital

    Stevenage,
    United Kingdom

    Active - Recruiting

  • Sunderland Royal Hospital

    Sunderland, SR4 7TP
    United Kingdom

    Active - Recruiting

  • Swansea Bay UHB Singleton Hospital

    Swansea,
    United Kingdom

    Active - Recruiting

  • Torbay Hospital

    Torquay,
    United Kingdom

    Site Not Available

  • Birmingham VAHCS

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Mayo Clinic

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Florida Cancer Specialist and Research Institute

    Orlando, Florida 32827
    United States

    Active - Recruiting

  • Protean Biodiagnosics

    Orlando, Florida 32827
    United States

    Active - Recruiting

  • Northwest Community Healthcare

    Rolling Meadows, Illinois 60008
    United States

    Active - Recruiting

  • Helen Nassif Community Cancer Center

    Cedar Rapids, Iowa 52403
    United States

    Active - Recruiting

  • Rutgers Cancer Institute

    New Brunswick, New Jersey 08903
    United States

    Active - Recruiting

  • Roswell Park

    Buffalo, New York 14263
    United States

    Active - Recruiting

  • West Clinic

    Germantown, Tennessee 38138
    United States

    Active - Recruiting

  • Michael E. Debakey VA Medical Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • 151-Christus Health St. Michael

    Texarkana, Texas 75503
    United States

    Active - Recruiting

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