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Trial Title:
Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments, Using Multiomics
NCT ID:
NCT05736029
Condition:
Non Small Cell Lung Cancer
Healthy
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
blood, stool and tissue samples collection
Description:
blood, stool and tissue samples collection before and during the treatment, as applicable
Arm group label:
Healthy volunteers
Arm group label:
Non-operable NSCLC patients receiving ICI therapy
Arm group label:
Operable NSCLC Patients Receiving ICI as Neoadjuvant or Adjuvant Therapy
Summary:
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)
Criteria for eligibility:
Study pop:
Study population comprises 3 sub-populations:
Cohort 1 - Non-operable NSCLC (Stages IIIB to IV), receiving immune-check inhibitor (ICI)
therapy [any combination of ICI / ICI ±Chemotherapy, and any line of treatment].
Cohort 2 - Operable NSCLC (Stages II-IIIA), receiving ICI in the neoadjuvant or adjuvant
setting.
Cohort 3 - Sex and aged matched non-diseased volunteers.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Baylor Scott and White Research Institute
Address:
City:
Dallas
Zip:
75204
Country:
United States
Status:
Recruiting
Contact:
Last name:
Pappu Himabindu
Email:
Himabindu.Pappu@BSWHealth.org
Investigator:
Last name:
Ronan J Kelly, MD MBA
Email:
Principal Investigator
Start date:
November 7, 2022
Completion date:
June 30, 2028
Lead sponsor:
Agency:
OncoHost Ltd.
Agency class:
Industry
Source:
OncoHost Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05736029
