Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments (PROPHETIC)
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ClinicalTrials.gov Identifier: NCT04056247 |
Recruitment Status :
Recruiting
First Posted : August 14, 2019
Last Update Posted : August 29, 2023
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Condition or disease | Intervention/treatment |
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Stage IV Non-small Cell Lung Cancer Stage IV Malignant Melanoma Stage IV Small Cell Lung Cancer Stage III Malignant Melanoma | Other: Plasma sample collection |
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.
Study Type : | Observational |
Estimated Enrollment : | 2000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | PROPHETIC - Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments |
Actual Study Start Date : | October 1, 2019 |
Estimated Primary Completion Date : | October 1, 2029 |
Estimated Study Completion Date : | October 1, 2029 |
Group/Cohort | Intervention/treatment |
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Newly diagnosed NSCLC stage IV
Patients with newly diagnosed stage IV NSCLC treated with Immunotherapy or Immunotherapy + Chemotherapy.
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Other: Plasma sample collection
Collect at least two plasma samples |
NSCLC stage IV 2nd line and further of immunotherapy
Patients with NSCLC stage IV treated with Immunotherapy at 2nd line or consecutive lines.
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Other: Plasma sample collection
Collect at least two plasma samples |
Malignant melanoma stage IV
Patients with stage IV malignant melanoma treated with Immunotherapy with or without targeted therapy.
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Other: Plasma sample collection
Collect at least two plasma samples |
Malignant melanoma stage IIIb-d
Patients with stage IIIb-d malignant melanoma treated with Immunotherapy as adjuvant therapy.
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Other: Plasma sample collection
Collect at least two plasma samples |
SCLC stage IV
Patients with stage IV SCLC treated with Immunotherapy or Immunotherapy + Chemotherapy.
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Other: Plasma sample collection
Collect at least two plasma samples |
- Overall response rate (ORR) at 3 months [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At baseline (pre-therapy) and after 1st dose administration (post therapy) ]Changes in Blood levels of proteins representing the Host response
- Adverse Events (AE) [ Time Frame: At second blood collection, 3 months and 6 months after treatment and EOS (2 years) ]AE, as reported by the patients
- Progression Free Survival (PFS) [ Time Frame: At End of study (2 years) ]Collect Progression Free Survival (PFS) dates
- Overall Survival (OS) [ Time Frame: At End of study (2 years) ]Collect Overall Survival (OS) dates
- Duration of Response (DOR) [ Time Frame: At End of study (2 years) ]Collect Duration of Response (DOR) dates
Biospecimen Retention: Samples Without DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
- Patients with newly diagnosed stage IV NSCLC treated with Immunotherapy or Immunotherapy + Chemotherapy.
- Patients with NSCLC stage IV treated with Immunotherapy at 2nd line or consecutive lines.
- Patients with stage IV malignant melanoma treated with Immunotherapy with or without targeted therapy.
- Patients with stage IIIb-d malignant melanoma treated with Immunotherapy as adjuvant therapy.
- Patients with stage IV SCLC treated with Immunotherapy or Immunotherapy + Chemotherapy.
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 to enable assessment of response
- ECOG PS - 0/1-2
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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 ≤1.4 mg/dL, or creatinine clearance higher than 40 mL/min
- Total bilirubin lower than 1.5 mg/dL, ALT and AST levels ≤ 3 times above the upper normal limit.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056247
Contact: Shani Raveh Shoval, Ph.D. | 97248537554 | shani@oncohost.com |
Principal Investigator: | Alona Zer, MD | 003 Rambam Medical Center | |
Principal Investigator: | Michal Lotem, MD | 001 Hadassah Medical Center | |
Principal Investigator: | Jair Bar, MD | 016 Sheba Medical Center | |
Principal Investigator: | Maya Gottfried, MD | 005 Meir Medical Center | |
Principal Investigator: | Abed Agbaria, MD | 004 Bnai Zion Medical Center | |
Principal Investigator: | Ido Wolf, MD | 002 Tel Aviv Sourasky Medical Center | |
Principal Investigator: | Mahmud Abu-Amana, MD | 007 Haemek Medical Center | |
Principal Investigator: | Rivka Katsenelson, MD | 008 Kaplan Medical Center | |
Principal Investigator: | Alexander Yakobson, MD | 009 Soroka Medical Center | |
Principal Investigator: | Tatiana Harkovsky, MD | 011 Barzilai Medical Center | |
Principal Investigator: | Mor Moskovitz, MD | 012 Rabin Medical Center | |
Principal Investigator: | Elizabeta Dudnik, MD | 013 Assuta Medical Center | |
Principal Investigator: | Raya Leibowitz, MD | 014 Shamir Medical Center | |
Principal Investigator: | Adam Berger, MD | 030 Rutgers Cancer Institute | |
Principal Investigator: | Jose Lutzky, MD | 032 University of Miami | |
Principal Investigator: | Antony Magliocco, MD | 015 Protean Biodiagnostics | |
Principal Investigator: | Gillian Price, MD | 020 Aberdeen Royal Infirmary | |
Principal Investigator: | Helen Cheley | 021 Swansea Bay UHB - Cancer Institute | |
Principal Investigator: | Louise Medley, MD | 022 Torbay and South Devon NHS foundation | |
Principal Investigator: | Tom Geldart, MD | 023 Royal Bournemouth General Hospital Dorset | |
Principal Investigator: | Anirban Chatterjee, MD | 024 The Shrewsbury and Telford Hospital | |
Principal Investigator: | David Farrugia, MD | 025 Cheltenham General Hospital | |
Principal Investigator: | Andreas Polychronis, MD | 026 Mount Vernon Cancer Centre | |
Principal Investigator: | Andreas Polychronis, MD | 027 Lister Hospital | |
Principal Investigator: | Ari VanderWalde, MD | 031 West Clinic | |
Principal Investigator: | Davika Das, MD | 033 VAHCS Birmingham | |
Principal Investigator: | Alison Brewster, MD | 051 Withybush Hospital Hawl Dda University Health Board | |
Principal Investigator: | Adam Hassani | 029 Sunderland Royal Hospital | |
Principal Investigator: | Adam Hassani, MD | 028 South Tyneside District | |
Principal Investigator: | Andrew Conn, MD | 050 Bradford Teaching Hospitals | |
Principal Investigator: | Yanyan Lou, MD | 034 Mayo Clinic | |
Principal Investigator: | Igor Puzanov, MD | 035 Roswell Park | |
Principal Investigator: | Ernesto Bustinza, MD | 153 Florida Cancer Specialists and Research Institute | |
Principal Investigator: | Anita Sabichi, MD | 036 Michael E Debakey VA Medical Center | |
Principal Investigator: | Ronnie Shapira Frommer, MD | 017 Sheba Medical Center | |
Principal Investigator: | Ina Koch, PhD | 040 Asklepios Klinik Gauting GmbH | |
Principal Investigator: | Petros Christopoulos, MD | 041 Thoraxklinik-Heidelberg gGmbH | |
Principal Investigator: | Marina Messinger, MD | 150 Northwest Community Healthcare | |
Principal Investigator: | Sunil Patel, MD | 151 CHRISTUS St. Michael Health System | |
Principal Investigator: | William P Fusselman, MD | 152 Physicians Clinic of Iowa | |
Principal Investigator: | David Vecente, MD | 044 Hospital Universitario Virgen Macarena |
Responsible Party: | OncoHost Ltd. |
ClinicalTrials.gov Identifier: | NCT04056247 |
Other Study ID Numbers: |
OH-HRPP-001 |
First Posted: | August 14, 2019 Key Record Dates |
Last Update Posted: | August 29, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Lung Neoplasms Melanoma Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic |
Bronchial Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas Skin Neoplasms Skin Diseases |