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

Part of paid clinical trials in Dallas, Texas.

Sponsor
OncoHost Ltd.
Study ID
NCT05736029
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 7, 2022
Status verified
Feb 2023
Primary completion
Jan 1, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
350 participants (estimated)

Arms

  • Arm: 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
  • Arm: 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
  • Arm: Healthy volunteers
    Sex and aged matched non-diseased volunteers

Primary Outcome Measure

Overall response (OR) [ Time Frame: month 3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor Scott and White Research InstituteDallasTexas75204
Pappu Himabindu
Ronan J Kelly, MD MBA (PRINCIPAL_INVESTIGATOR)

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