Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments
- Conditions
- Stage IV Non-small Cell Lung CancerStage IV Malignant MelanomaStage IV Small Cell Lung CancerStage III Malignant Melanoma
- Interventions
- Other: Plasma sample collection
- Registration Number
- NCT04056247
- Lead Sponsor
- OncoHost Ltd.
- Brief Summary
This study will develop an algorithm of identifying patients with stage IV NSCLC and Melanoma who could benefit from cancer treatment they receive.
- 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, 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
-
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:
- Absolute neutrophil count higher than 1500/mm3
- Platelets count higher than 100,000/mm3
- haemoglobin higher than 9 g/dL
- Creatinine concentration ā¤1.4 mg/dL, or creatinine clearance higher than 40 mL/min
- Total bilirubin lower than 1.5 mg/dL, ALT and AST levels ā¤ 3 times above the upper normal limit.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Newly diagnosed NSCLC stage IV Plasma sample collection Patients with newly diagnosed stage IV NSCLC treated with Immunotherapy or Immunotherapy + Chemotherapy. NSCLC stage IV 2nd line and further of immunotherapy Plasma sample collection Patients with NSCLC stage IV treated with Immunotherapy at 2nd line or consecutive lines. Malignant melanoma stage IV Plasma sample collection Patients with stage IV malignant melanoma treated with Immunotherapy with or without targeted therapy. Malignant melanoma stage IIIb-d Plasma sample collection Patients with stage IIIb-d malignant melanoma treated with Immunotherapy as adjuvant therapy. SCLC stage IV Plasma sample collection Patients with stage IV SCLC treated with Immunotherapy or Immunotherapy + Chemotherapy.
- Primary Outcome Measures
Name Time Method Overall response rate (ORR) at 3 months At 3 months after therapy ORR as defined by RECIST 1.1 or other validated method for ORR evaluation
Overall response rate (ORR) at 6 months At 6 months after therapy ORR as defined by RECIST 1.1 or other validated method for ORR evaluation
Changes in the blood levels of different proteins that represent the host response At baseline (pre-therapy) and after 1st dose administration (post therapy) Changes in Blood levels of proteins representing the Host response
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (41)
Shamir Medical Center
š®š±Be'er Ya'aqov, Israel
Rambam Medical Center
š®š±Haifa, Israel
Meir medical center
š®š±Kfar Saba, Israel
Royal Bournemouth General Hospital
š¬š§Bournemouth, United Kingdom
Rutgers Cancer Institute
šŗšøNew Brunswick, New Jersey, United States
Helen Nassif Community Cancer Center
šŗšøCedar Rapids, Iowa, United States
Mayo Clinic
šŗšøJacksonville, Florida, United States
Northwest Community Healthcare
šŗšøRolling Meadows, Illinois, United States
Roswell Park
šŗšøBuffalo, New York, United States
Asklepois
š©šŖGauting, Germany
West Clinic
šŗšøGermantown, Tennessee, United States
151-Christus Health St. Michael
šŗšøTexarkana, Texas, United States
Thoraxklinik Heidelberg gGmbH
š©šŖHeidelberg, Germany
Barzilai Medical Center
š®š±Ashkelon, Israel
Haemek Medical Center
š®š±Afula, Israel
Soroka Medical Center
š®š±Be'er Sheva, Israel
Bnai Zion Medical Center
š®š±Haifa, Israel
Rabin Medical Center
š®š±Petah tikva, Israel
Hadassah Medcial Center
š®š±Jerusalem, Israel
Kaplan Medical Center
š®š±Reįŗovot, Israel
Assuta Medical Cetner
š®š±Tel Aviv, Israel
Sheba Medical Center
š®š±Tel Aviv, Israel
Sourasky Medical Center
š®š±Tel Aviv, Israel
Sheba medical center
š®š±Tel HaShomer, Israel
044 Hospital Universitario Virgen Macarena
šŖšøSeville, Spain
Aberdeen Royal Infirmary
š¬š§Aberdeen, United Kingdom
Bradford Teaching Hospitals
š¬š§Bradford, United Kingdom
Withybush Hospital
š¬š§Haverfordwest, United Kingdom
Cheltenham General Hospital
š¬š§Cheltenham, United Kingdom
Mount Vernon Cancer Centre
š¬š§Northwood, United Kingdom
Swansea Bay UHB Singleton Hospital
š¬š§Swansea, United Kingdom
The Shrewsbury and Telford Hospital
š¬š§Shrewsbury, United Kingdom
South Tyneside
š¬š§South Shields, United Kingdom
Lister Hospital
š¬š§Stevenage, United Kingdom
Sunderland Royal Hospital
š¬š§Sunderland, United Kingdom
Torbay Hospital
š¬š§Torquay, United Kingdom
Michael E. Debakey VA Medical Center
šŗšøHouston, Texas, United States
Birmingham VAHCS
šŗšøBirmingham, Alabama, United States
University of Miami
šŗšøMiami, Florida, United States
Florida Cancer Specialist and Research Institute
šŗšøOrlando, Florida, United States
Protean Biodiagnosics
šŗšøOrlando, Florida, United States