ACTIVE_NOT_RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-10-01

Study Completion:2029-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04056247

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* 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.

Contacts and Locations

Principal Investigator

Alona Zer, MD

PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Michal Lotem, MD

PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Jair Bar, MD

PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Maya Gottfried, MD

PRINCIPAL_INVESTIGATOR

Meir Medical Center

Abed Agbaria, MD

PRINCIPAL_INVESTIGATOR

Bnai Zion Medical Center

Ido Wolf, MD

PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Mahmud Abu-Amana, MD

PRINCIPAL_INVESTIGATOR

haemek medical center

Rivka Katsenelson, MD

PRINCIPAL_INVESTIGATOR

Kaplan Medical Center

Alexander Yakobson, MD

PRINCIPAL_INVESTIGATOR

Soroka University Medical Center

Tatiana Harkovsky, MD

PRINCIPAL_INVESTIGATOR

Barzilai Medical Center

Mor Moskovitz, MD

PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Elizabeta Dudnik, MD

PRINCIPAL_INVESTIGATOR

Assuta Medical Center

Raya Leibowitz, MD

PRINCIPAL_INVESTIGATOR

Assaf-Harofeh Medical Center

Adam Berger, MD

PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute

Jose Lutzky, MD

PRINCIPAL_INVESTIGATOR

University of Miami

Antony Magliocco, MD

PRINCIPAL_INVESTIGATOR

Protean BioDiagnostics

Gillian Price, MD

PRINCIPAL_INVESTIGATOR

Aberdeen Royal Infirmary

Helen Cheley

PRINCIPAL_INVESTIGATOR

Swansea Bay UHB - Cancer Institute

Louise Medley, MD

PRINCIPAL_INVESTIGATOR

Torbay and South Devon NHS foundation

Tom Geldart, MD

PRINCIPAL_INVESTIGATOR

Royal Bournemouth General Hospital Dorset

Anirban Chatterjee, MD

PRINCIPAL_INVESTIGATOR

The Shrewsbury and Telford Hospital

Sean Brown, MD

PRINCIPAL_INVESTIGATOR

Gloucestershire Hospitals NHS Foundation Trust

Andreas Polychronis, MD

PRINCIPAL_INVESTIGATOR

Mount Vernon Cancer Centre

Andreas Polychronis, MD

PRINCIPAL_INVESTIGATOR

Lister Hospital

Ari VanderWalde, MD

PRINCIPAL_INVESTIGATOR

West Clinic

Davika Das, MD

PRINCIPAL_INVESTIGATOR

VAHCS Birmingham

Alison Brewster, MD

PRINCIPAL_INVESTIGATOR

Withybush Hospital Hawl Dda University Health Board

Adam Hassani

PRINCIPAL_INVESTIGATOR

Sunderland Royal Hospital

Adam Hassani, MD

PRINCIPAL_INVESTIGATOR

South Tyneside District

Andrew Conn, MD

PRINCIPAL_INVESTIGATOR

Bradford Teaching Hospitals

Yanyan Lou, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Igor Puzanov, MD

PRINCIPAL_INVESTIGATOR

Roswell Park

Ernesto Bustinza, MD

PRINCIPAL_INVESTIGATOR

Florida Cancer Specialists and Research Institute

Huang Quillan, MD

PRINCIPAL_INVESTIGATOR

Michael E. DeBakey VA Medical Center

Ronnie Shapira Frommer, MD

PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Astrid Ammendola, MD

PRINCIPAL_INVESTIGATOR

Asklepios Klinik Gauting GmbH

Petros Christopoulos, MD

PRINCIPAL_INVESTIGATOR

Thoraxklinik-Heidelberg gGmbH

Marina Messinger, MD

PRINCIPAL_INVESTIGATOR

Northwest Community Healthcare

Sunil Patel, MD

PRINCIPAL_INVESTIGATOR

CHRISTUS St. Michael Health System

Bharat P Jenigiri, MD

PRINCIPAL_INVESTIGATOR

Physicians Clinic of Iowa

David Vecente, MD

PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen Macarena

Eugenie Younger, MD

PRINCIPAL_INVESTIGATOR

Gloucestershire Hospitals NHS Foundation Trust

Study Locations (Sites)

Birmingham VAHCS

Birmingham, Alabama, 35233

United States

Mayo Clinic

Jacksonville, Florida, 32224

United States

University of Miami

Miami, Florida, 33136

United States

Florida Cancer Specialist and Research Institute

Orlando, Florida, 32827

United States

Protean Biodiagnosics

Orlando, Florida, 32827

United States

Northwest Community Healthcare

Rolling Meadows, Illinois, 60008

United States

Helen Nassif Community Cancer Center

Cedar Rapids, Iowa, 52403

United States

Rutgers Cancer Institute

New Brunswick, New Jersey, 08903

United States

Roswell Park

Buffalo, New York, 14263

United States

West Clinic

Germantown, Tennessee, 38138

United States

Michael E. Debakey VA Medical Center

Houston, Texas, 77030

United States

151-Christus Health St. Michael

Texarkana, Texas, 75503

United States

Collaborators and Investigators

Sponsor: OncoHost Ltd.

Alona Zer, MD, PRINCIPAL_INVESTIGATOR, Rambam Health Care Campus
Michal Lotem, MD, PRINCIPAL_INVESTIGATOR, Hadassah Medical Organization
Jair Bar, MD, PRINCIPAL_INVESTIGATOR, Sheba Medical Center
Maya Gottfried, MD, PRINCIPAL_INVESTIGATOR, Meir Medical Center
Abed Agbaria, MD, PRINCIPAL_INVESTIGATOR, Bnai Zion Medical Center
Ido Wolf, MD, PRINCIPAL_INVESTIGATOR, Tel-Aviv Sourasky Medical Center
Mahmud Abu-Amana, MD, PRINCIPAL_INVESTIGATOR, haemek medical center
Rivka Katsenelson, MD, PRINCIPAL_INVESTIGATOR, Kaplan Medical Center
Alexander Yakobson, MD, PRINCIPAL_INVESTIGATOR, Soroka University Medical Center
Tatiana Harkovsky, MD, PRINCIPAL_INVESTIGATOR, Barzilai Medical Center
Mor Moskovitz, MD, PRINCIPAL_INVESTIGATOR, Rabin Medical Center
Elizabeta Dudnik, MD, PRINCIPAL_INVESTIGATOR, Assuta Medical Center
Raya Leibowitz, MD, PRINCIPAL_INVESTIGATOR, Assaf-Harofeh Medical Center
Adam Berger, MD, PRINCIPAL_INVESTIGATOR, Rutgers Cancer Institute
Jose Lutzky, MD, PRINCIPAL_INVESTIGATOR, University of Miami
Antony Magliocco, MD, PRINCIPAL_INVESTIGATOR, Protean BioDiagnostics
Gillian Price, MD, PRINCIPAL_INVESTIGATOR, Aberdeen Royal Infirmary
Helen Cheley, PRINCIPAL_INVESTIGATOR, Swansea Bay UHB - Cancer Institute
Louise Medley, MD, PRINCIPAL_INVESTIGATOR, Torbay and South Devon NHS foundation
Tom Geldart, MD, PRINCIPAL_INVESTIGATOR, Royal Bournemouth General Hospital Dorset
Anirban Chatterjee, MD, PRINCIPAL_INVESTIGATOR, The Shrewsbury and Telford Hospital
Sean Brown, MD, PRINCIPAL_INVESTIGATOR, Gloucestershire Hospitals NHS Foundation Trust
Andreas Polychronis, MD, PRINCIPAL_INVESTIGATOR, Mount Vernon Cancer Centre
Andreas Polychronis, MD, PRINCIPAL_INVESTIGATOR, Lister Hospital
Ari VanderWalde, MD, PRINCIPAL_INVESTIGATOR, West Clinic
Davika Das, MD, PRINCIPAL_INVESTIGATOR, VAHCS Birmingham
Alison Brewster, MD, PRINCIPAL_INVESTIGATOR, Withybush Hospital Hawl Dda University Health Board
Adam Hassani, PRINCIPAL_INVESTIGATOR, Sunderland Royal Hospital
Adam Hassani, MD, PRINCIPAL_INVESTIGATOR, South Tyneside District
Andrew Conn, MD, PRINCIPAL_INVESTIGATOR, Bradford Teaching Hospitals
Yanyan Lou, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic
Igor Puzanov, MD, PRINCIPAL_INVESTIGATOR, Roswell Park
Ernesto Bustinza, MD, PRINCIPAL_INVESTIGATOR, Florida Cancer Specialists and Research Institute
Huang Quillan, MD, PRINCIPAL_INVESTIGATOR, Michael E. DeBakey VA Medical Center
Ronnie Shapira Frommer, MD, PRINCIPAL_INVESTIGATOR, Sheba Medical Center
Astrid Ammendola, MD, PRINCIPAL_INVESTIGATOR, Asklepios Klinik Gauting GmbH
Petros Christopoulos, MD, PRINCIPAL_INVESTIGATOR, Thoraxklinik-Heidelberg gGmbH
Marina Messinger, MD, PRINCIPAL_INVESTIGATOR, Northwest Community Healthcare
Sunil Patel, MD, PRINCIPAL_INVESTIGATOR, CHRISTUS St. Michael Health System
Bharat P Jenigiri, MD, PRINCIPAL_INVESTIGATOR, Physicians Clinic of Iowa
David Vecente, MD, PRINCIPAL_INVESTIGATOR, Hospital Universitario Virgen Macarena
Eugenie Younger, MD, PRINCIPAL_INVESTIGATOR, Gloucestershire Hospitals NHS Foundation Trust

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-10-01

Study Completion Date2029-10-01

Study Record Updates

Study Start Date2019-10-01

Study Completion Date2029-10-01

Terms related to this study

Keywords Provided by Researchers

Non-small Cell Lung Cancer
Small Cell Lung Cancer
Malignant Melanoma

Additional Relevant MeSH Terms

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