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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-07

Study Completion Date

2028-06-30

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Non Small Cell Lung Cancer Healthy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-operable NSCLC patients receiving ICI therapy

Patients with non-operable stage IIIB-IV NSCLC treated with immune check inhibitor anti cancer treatment as a standard of care

blood, stool and tissue samples collection

Intervention Type OTHER

blood, stool and tissue samples collection before and during the treatment, as applicable

Operable NSCLC Patients Receiving ICI as Neoadjuvant or Adjuvant Therapy

Patients with operable stage II-IIIA NSCLC, treated with immune check inhibitor in the neoadjuvant or adjuvant setting

blood, stool and tissue samples collection

Intervention Type OTHER

blood, stool and tissue samples collection before and during the treatment, as applicable

Healthy volunteers

Sex and aged matched non-diseased volunteers

blood, stool and tissue samples collection

Intervention Type OTHER

blood, stool and tissue samples collection before and during the treatment, as applicable

Interventions

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blood, stool and tissue samples collection

blood, stool and tissue samples collection before and during the treatment, as applicable

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes