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Clinical Trials in Israel / NCT04056247
Active, not recruiting Observational

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

NCT04056247 · tracked via the Priya Life Science Israel tracker
Sponsor
OncoHost Ltd
Phase
Observational
Started
2019-10-01
Last updated
2025-10-15

Condition(s) studied

Stage IV Non-small Cell Lung CancerStage IV Malignant MelanomaStage IV Small Cell Lung CancerStage III Unresectable Non-Small Cell Lung CancerStage IIIb-d Malignant Melanoma

Investigational drug(s) / intervention(s)

Plasma sample collection

Plasma sample collection: Collect at least two plasma samples

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 40 mL/min 5. 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.

Primary outcome measure(s)

  • Measured biological features at baseline (pre-treatment) and after 1st dose administration (on-treatment) and during treatment (optional) — Measured biological features are analyzed in samples taken at baseline (prior treatment) and after the 1st dose administration (on-treatment) and during treatment (optional)
    Biological features are analyzed in biological samples taken from the patients as part of the study
  • Overall response as determined by RECIST 1.1 or any other validated clinical scales for response, every 3 months or according to the standard of care — Every 3 months or according to the standard of care
    Overall response as determined by RECIST 1.1 or any other validated clinical scales for response, every 3 months or according to the standard of care
  • Progression Free Survival (PFS) — At progression during treatment
    Collect Progression Free Survival (PFS) dates
  • Overall survival or last follow-up — Overall survival or last follow-up
    Collect overall survival or last follow-up dates

Trial sites (41)

FacilityCityRegionStatus
Birmingham VAHCS Birmingham Alabama
Mayo Clinic Jacksonville Florida
University of Miami Miami Florida
Florida Cancer Specialist and Research Institute Orlando Florida
Protean Biodiagnosics Orlando Florida
Northwest Community Healthcare Rolling Meadows Illinois
Helen Nassif Community Cancer Center Cedar Rapids Iowa
Rutgers Cancer Institute New Brunswick New Jersey
Roswell Park Buffalo New York
West Clinic Germantown Tennessee
Michael E. Debakey VA Medical Center Houston Texas
151-Christus Health St. Michael Texarkana Texas
Asklepois Gauting Germany
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Haemek Medical Center Afula Israel
Barzilai Medical Center Ashkelon Israel
Soroka Medical Center Beersheba Israel
Shamir Medical Center Be’er Ya‘aqov Israel
Bnai Zion Medical Center Haifa Israel
Rambam Medical Center Haifa Israel
Hadassah Medcial Center Jerusalem Israel
Meir medical center Kfar Saba Israel
Rabin Medical Center Petah Tikva Israel
Kaplan Medical Center Rehovot Israel
Assuta Medical Cetner Tel Aviv Israel
Sheba Medical Center Tel Aviv Israel
Sourasky Medical Center Tel Aviv Israel
Sheba medical center Tel Litwinsky Israel
044 Hospital Universitario Virgen Macarena Seville Spain
Aberdeen Royal Infirmary Aberdeen United Kingdom
Royal Bournemouth General Hospital Bournemouth United Kingdom
Bradford Teaching Hospitals Bradford United Kingdom
Cheltenham General Hospital Cheltenham United Kingdom
Withybush Hospital Haverfordwest United Kingdom
Mount Vernon Cancer Centre Northwood United Kingdom
The Shrewsbury and Telford Hospital Shrewsbury United Kingdom
South Tyneside South Shields United Kingdom
Lister Hospital Stevenage United Kingdom
Sunderland Royal Hospital Sunderland United Kingdom
Swansea Bay UHB Singleton Hospital Swansea United Kingdom

+ 1 more sites — see the full list on the official registry below.

Other trials for the same condition

Maintenance Chemotherapy With or Without Local Consolidative Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04056247 on ClinicalTrials.gov ↗ ← All trials in Israel