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Brief Title: Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments
Official Title: PROPHETIC - Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments
Study ID: NCT04056247
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Birmingham VAHCS, Birmingham, Alabama, United States
Mayo Clinic, Jacksonville, Florida, United States
University of Miami, Miami, Florida, United States
Florida Cancer Specialist and Research Institute, Orlando, Florida, United States
Protean Biodiagnosics, Orlando, Florida, United States
Northwest Community Healthcare, Rolling Meadows, Illinois, United States
Helen Nassif Community Cancer Center, Cedar Rapids, Iowa, United States
Rutgers Cancer Institute, New Brunswick, New Jersey, United States
Roswell Park, Buffalo, New York, United States
West Clinic, Germantown, Tennessee, United States
Michael E. Debakey VA Medical Center, Houston, Texas, United States
151-Christus Health St. Michael, Texarkana, Texas, United States
Asklepois, Gauting, , Germany
Thoraxklinik Heidelberg gGmbH, Heidelberg, , Germany
Haemek Medical Center, Afula, , Israel
Barzilai Medical Center, Ashkelon, , Israel
Soroka Medical Center, Be'er Sheva, , 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, Reẖovot, , Israel
Assuta Medical Cetner, Tel Aviv, , Israel
Sheba Medical Center, Tel Aviv, , Israel
Sourasky Medical Center, Tel Aviv, , Israel
Sheba medical center, Tel HaShomer, , 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
Torbay Hospital, Torquay, , United Kingdom
Name: Alona Zer, MD
Affiliation: 003 Rambam Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Michal Lotem, MD
Affiliation: 001 Hadassah Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Jair Bar, MD
Affiliation: 016 Sheba Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Maya Gottfried, MD
Affiliation: 005 Meir Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Abed Agbaria, MD
Affiliation: 004 Bnai Zion Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Ido Wolf, MD
Affiliation: 002 Tel Aviv Sourasky Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Mahmud Abu-Amana, MD
Affiliation: 007 Haemek Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Rivka Katsenelson, MD
Affiliation: 008 Kaplan Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Alexander Yakobson, MD
Affiliation: 009 Soroka Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Tatiana Harkovsky, MD
Affiliation: 011 Barzilai Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Mor Moskovitz, MD
Affiliation: 012 Rabin Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Elizabeta Dudnik, MD
Affiliation: 013 Assuta Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Raya Leibowitz, MD
Affiliation: 014 Shamir Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Adam Berger, MD
Affiliation: 030 Rutgers Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Jose Lutzky, MD
Affiliation: 032 University of Miami
Role: PRINCIPAL_INVESTIGATOR
Name: Antony Magliocco, MD
Affiliation: 015 Protean Biodiagnostics
Role: PRINCIPAL_INVESTIGATOR
Name: Gillian Price, MD
Affiliation: 020 Aberdeen Royal Infirmary
Role: PRINCIPAL_INVESTIGATOR
Name: Helen Cheley
Affiliation: 021 Swansea Bay UHB - Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Louise Medley, MD
Affiliation: 022 Torbay and South Devon NHS foundation
Role: PRINCIPAL_INVESTIGATOR
Name: Tom Geldart, MD
Affiliation: 023 Royal Bournemouth General Hospital Dorset
Role: PRINCIPAL_INVESTIGATOR
Name: Anirban Chatterjee, MD
Affiliation: 024 The Shrewsbury and Telford Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: David Farrugia, MD
Affiliation: 025 Cheltenham General Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Andreas Polychronis, MD
Affiliation: 026 Mount Vernon Cancer Centre
Role: PRINCIPAL_INVESTIGATOR
Name: Andreas Polychronis, MD
Affiliation: 027 Lister Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Ari VanderWalde, MD
Affiliation: 031 West Clinic
Role: PRINCIPAL_INVESTIGATOR
Name: Davika Das, MD
Affiliation: 033 VAHCS Birmingham
Role: PRINCIPAL_INVESTIGATOR
Name: Alison Brewster, MD
Affiliation: 051 Withybush Hospital Hawl Dda University Health Board
Role: PRINCIPAL_INVESTIGATOR
Name: Adam Hassani
Affiliation: 029 Sunderland Royal Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Adam Hassani, MD
Affiliation: 028 South Tyneside District
Role: PRINCIPAL_INVESTIGATOR
Name: Andrew Conn, MD
Affiliation: 050 Bradford Teaching Hospitals
Role: PRINCIPAL_INVESTIGATOR
Name: Yanyan Lou, MD
Affiliation: 034 Mayo Clinic
Role: PRINCIPAL_INVESTIGATOR
Name: Igor Puzanov, MD
Affiliation: 035 Roswell Park
Role: PRINCIPAL_INVESTIGATOR
Name: Ernesto Bustinza, MD
Affiliation: 153 Florida Cancer Specialists and Research Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Anita Sabichi, MD
Affiliation: 036 Michael E Debakey VA Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Ronnie Shapira Frommer, MD
Affiliation: 017 Sheba Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Ina Koch, PhD
Affiliation: 040 Asklepios Klinik Gauting GmbH
Role: PRINCIPAL_INVESTIGATOR
Name: Petros Christopoulos, MD
Affiliation: 041 Thoraxklinik-Heidelberg gGmbH
Role: PRINCIPAL_INVESTIGATOR
Name: Marina Messinger, MD
Affiliation: 150 Northwest Community Healthcare
Role: PRINCIPAL_INVESTIGATOR
Name: Sunil Patel, MD
Affiliation: 151 CHRISTUS St. Michael Health System
Role: PRINCIPAL_INVESTIGATOR
Name: William P Fusselman, MD
Affiliation: 152 Physicians Clinic of Iowa
Role: PRINCIPAL_INVESTIGATOR
Name: David Vecente, MD
Affiliation: 044 Hospital Universitario Virgen Macarena
Role: PRINCIPAL_INVESTIGATOR