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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04056247
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Stage IV Non-small Cell Lung Cancer Stage IV Malignant Melanoma Other: Plasma sample collection

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.

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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, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Group/Cohort Intervention/treatment
NSCLC stage IV Immunotherapy and Chemotherapy
Patients with newly diagnosed stage IV NSCLC treated with Immunotherapy or Immunotherapy and Chemotherapy
Other: Plasma sample collection
Collect two plasma samples

NSCLC stage IV 2nd line immunotherapy
Patients with NSCLC stage IV treated with Immunotherapy at 2nd line or consecutive lines.
Other: Plasma sample collection
Collect two plasma samples

NSCLC stage IV chemotherapy and radiotherapy
Patients with Stage IV NSCLC treated with Chemotherapy and Chemotherapy + Radiotherapy
Other: Plasma sample collection
Collect two plasma samples

MM stage IV
Patients with stage IV malignant melanoma treated with Immunotherapy
Other: Plasma sample collection
Collect two plasma samples

MM stage IIIb-d
Patients with stage IIIb-d malignant melanoma treated with Immunotherapy as adjuvant therapy



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Other Outcome Measures:
  1. Adverse Events (AE) [ Time Frame: At second blood collection, 3 months and 6 months after treatment ]
    AE, as reported by the patients


Biospecimen Retention:   Samples Without DNA
plasma samples.


Information from the National Library of Medicine

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.


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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
Study Population
  1. Patients with newly diagnosed stage IV NSCLC treated with Immunotherapy or Immunotherapy + Chemotherapy.
  2. Patients with NSCLC stage IV treated with Immunotherapy at 2nd line or consecutive lines.
  3. Patients with Stage IV NSCLC treated with Chemotherapy and Chemotherapy + Radiotherapy.
  4. Patients with stage IV malignant melanoma treated with Immunotherapy.
Criteria

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
  • 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.

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Galit Yahalom, Ph.D. 97248537554 galit@oncohost.com
Contact: Shani Raveh, Ph.D. 97248537554 shani@oncohost.com

Locations
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Israel
Haemek Medical Center Not yet recruiting
Afula, Israel
Contact: Mahmud Abu-Amana, MD    972-4-6495686    mahmud_ab@clalit.org.il   
Principal Investigator: Mahmud Abu-Amana, MD         
Sub-Investigator: Gil Bar-Sela, Prof.         
Sub-Investigator: Kamel Mahmid, MD         
Sub-Investigator: Olga Vornicova, MD         
Barzilai Medical Center Not yet recruiting
Ashkelon, Israel
Contact: Noam Asna, Md    972-8-6745378    noama@barzi.health.gov.il   
Principal Investigator: Noam Asna, MD         
Soroka Medical Center Not yet recruiting
Be'er Sheva, Israel
Contact: Alexander Yakobson, MD       Alexy@clalit.org.il   
Principal Investigator: Alexander Yakobson, MD         
Bnai Zion Medical Center Recruiting
Haifa, Israel
Contact: Abed Agbaria, MD    972-4835-9016    abed.agbarya@b-zion.org.il   
Principal Investigator: Abed Agbaria, MD         
Sub-Investigator: Ella Kozliner, MD         
Sub-Investigator: Yelena Shechtman, MD         
Rambam Medical Center Recruiting
Haifa, Israel
Contact: Mor, MD    9724-7776700    m_moskovitz@rambam.health.gov.il   
Principal Investigator: Mor Moskovitz, MD         
Sub-Investigator: Mira Wollner, MD         
Sub-Investigator: Mahamoud Abu Amna, MD         
Sub-Investigator: Talia Shentzer, MD         
Hadassah Medcial Center Recruiting
Jerusalem, Israel
Contact: Michal Lotem, Prof.    972-2677-6781    mlotem@hadassah.org.il   
Principal Investigator: Michal Lotem, Prof.         
Sub-Investigator: Hovav Hovav Nechushtan, Prof.         
Sub-Investigator: Jonathan Cohen, MD         
Sub-Investigator: Yakir Rottenberg, MD         
Sub-Investigator: Avner Mordechay, MD         
Meir medical center Recruiting
Kfar Saba, Israel
Contact: Maya Gottfried, MD    972-9747-2414    Maya.Gottfried@clalit.org.il   
Principal Investigator: Maya Gottfried, MD         
Sub-Investigator: Natalie Maimon-Rabinovich, MD         
Sub-Investigator: Moshe Mishaly, MD         
Rabin Medical Center Not yet recruiting
Petah tikva, Israel
Rabin medical center Not yet recruiting
Petah tikva, Israel
Contact: Alona Zer, MD    972-39378146    Alonaz@clalit.org.il   
Principal Investigator: Alona Zer, MD         
Sub-Investigator: Hendler Daniel, MD         
Kaplan Medical Center Not yet recruiting
Reẖovot, Israel
Contact: Rivka Katsenelson, MD    972-89441087    Rivka_K@clalit.org.il   
Principal Investigator: Rivka Katsenelson, MD         
Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel
Contact: Ido Wolf, Prof.    972-36925623    idow@tlvmc.gov.il   
Principal Investigator: Ido Wolf, Prof.         
Sub-Investigator: MOR MIODOVNIK, MD         
Sub-Investigator: ARI RAPHAEL, MD         
Sub-Investigator: OFER MERIMSKY, Prof.         
Sub-Investigator: SHULIM SHPIGEL, MD         
Sub-Investigator: FREDERIC SINAI, MD         
Sub-Investigator: HAGAI LIGUMSKY, MD         
Shiba medical center Not yet recruiting
Tel HaShomer, Israel
Contact: Jair Bar, MD    972-3530-7096    Yair.Bar@sheba.health.gov.il   
Principal Investigator: Jair Bar, MD         
Sub-Investigator: Amir Onn, MD         
Sub-Investigator: Sameh Daher, MD         
Sub-Investigator: Akram Saad, MD         
Sub-Investigator: Shirley Grinberg, MD         
Sub-Investigator: Ronen Shtoff, MD         
Sub-Investigator: Smadar Bauer, MD         
Sub-Investigator: Tamar Beller, MD         
Sponsors and Collaborators
OncoHost Ltd.
Investigators
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Principal Investigator: Mor Moskovitz, MD Rambam Health Care Campus
Principal Investigator: Michal Lotem, MD Hadassah Medical Center
Principal Investigator: Jair Bar, MD Sheba Medical Center
Principal Investigator: Maya Gottfried, MD Meir Medical Center
Principal Investigator: Abed Agbaria, MD Bnai Zion Medical Center
Principal Investigator: Ido Wolf, MD Tel-Aviv Sourasky Medical Center
Principal Investigator: Mahmud Abu-Amana, MD haemek medical center
Principal Investigator: Rivka Katsenelson, MD Kaplan Medical Center
Principal Investigator: Alexander Yakobson, MD Soroka University Medical Center
Principal Investigator: Noam Asna, MD Barzilai Medical Center
Principal Investigator: Alona Zer, MD Rabin Medical Center

Publications:
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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: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Immunologic Factors
Physiological Effects of Drugs