NCT05736029 · OncoHost Ltd.
Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments, Using Multiomics
(PROPHETIC)
What this study is about
The goal of this exploratory study is understand the mechanisms of response to immunotherapy in Non-Small Cell Lung Cancer patients.
View original scientific description
The goal of this exploratory study is understand the mechanisms of response to immunotherapy in Non-Small Cell Lung Cancer patients. The investigators are going to search for correlation between specific biological features and response to immunotherapy, and to use those associations for developing an algorithm enabling to identify patients that could benefit from the immune check inhibitor based anti cancer treatment. Patients will provide biological samples before and during their treatment, and clinical data will be collected.
Interventions
OTHER
blood, stool and tissue samples collection
blood, stool and tissue samples collection before and during the treatment, as applicable
Primary outcome measures
Overall response (OR)
Time frame: month 3
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Overall response (OR)
Time frame: month 6
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Overall response (OR)
Time frame: month 9
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Overall response (OR)
Time frame: month 12
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Overall response (OR)
Time frame: month 15
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Overall response (OR)
Time frame: month 18
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Overall response (OR)
Time frame: month 21
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Overall response (OR)
Time frame: month 24
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Plasma proteomic profile
Time frame: Baseline, pre treatment
Plasma proteins measurments
Plasma proteomic profile
Time frame: 2(+/-1) weeks from first treatment
Plasma proteins measurments
Plasma proteomic profile
Time frame: 3 months
Plasma proteins measurments
Plasma proteomic profile
Time frame: 6 months
Plasma proteins measurments
Plasma proteomic profile
Time frame: 9 months
Plasma proteins measurments
Plasma proteomic profile
Time frame: 12 months
Plasma proteins measurments
Plasma proteomic profile
Time frame: 15 months
Plasma proteins measurments
Plasma proteomic profile
Time frame: 18 months
Plasma proteins measurments
Plasma proteomic profile
Time frame: 21 months
Plasma proteins measurments
Plasma proteomic profile
Time frame: 24 months
Plasma proteins measurments
Epigenetic patterns
Time frame: Baseline, pre treatment
Characterization of Cell free DNA
Epigenetic patterns
Time frame: 2(+/-1) weeks from first treatment
Characterization of Cell free DNA
Epigenetic patterns
Time frame: 12 months
Characterization of Cell free DNA
Epigenetic patterns
Time frame: 24 months
Characterization of Cell free DNA
ctDNA mutation analysis
Time frame: immediately after surgery
ctDNA mutation analysis
Microbiome profiling
Time frame: Baseline, pre treatment
PBMC subpopulations exploration
Microbiome profiling
Time frame: 2(+/-1) weeks from first treatment
PBMC subpopulations exploration
Microbiome profiling
Time frame: 12 months
PBMC subpopulations exploration
Microbiome profiling
Time frame: 24 months
PBMC subpopulations exploration
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Provision of informed consent prior to any study-specific procedures.
- Male or female aged at least 18 years.
- ECOG PS - 0/1-2.
Exclusion criteria
- Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of treatment.
- Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study.
Where
- Dallas, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 21, 2023 · Source of record for eligibility and locations