Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments, Using Multiomics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: blood, stool and tissue samples collection.
- Who it may be relevant to
- Registry conditions: Non Small Cell Lung Cancer, Healthy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
PROPHETIC Extended - Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments, Extended Study.
Overview
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.
Detailed description
The goal of the study is to develop an algorithm that associates between biomarkers detected in biospecimen of NSCLC patients, and their:
* Response to treatment * Clinical benefit parameters such as PFS and OS. * Adverse events to immune check inhibitor therapy * Biological mechanisms involved in response or resistance to immune check inhibitor therapy.
Patients will provide plasma, PBMCs, stool and tissue samples (where applicable) before and during treatment.
Clinical data, including disease history, given treatment, response evaluation and adverse events to the treatment will be recorded.
Samples will be analysed as follows -
* Proteomic features (Plasma proteomics) * Epigenetic patterns (cell free DNA) * ctDNA mutation analysis * PBMC subpopulations * Microbiome profiling (Stool)
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]
- Overall response (OR) [Time frame: month 6]
- Overall response (OR) [Time frame: month 9]
- Overall response (OR) [Time frame: month 12]
- Overall response (OR) [Time frame: month 15]
- Overall response (OR) [Time frame: month 18]
- Overall response (OR) [Time frame: month 21]
- Overall response (OR) [Time frame: month 24]
- Plasma proteomic profile [Time frame: Baseline, pre treatment]
- Plasma proteomic profile [Time frame: 2(+/-1) weeks from first treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Baylor Scott and White Research Institute — Dallas
Identifiers
NCT: NCT05736029 · OH-HRPP-002