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Spots Global Cancer Trial Database for Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform

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Trial Identification

Brief Title: Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform

Official Title: Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform (CYBRID-01)

Study ID: NCT05478538

Study Description

Brief Summary: The primary objective of this study is to determine the ex-vivo prognostic accuracy of the Cybrid live tumor diagnostic platform using in-vivo RECIST 1.1 as the reference method.

Detailed Description: Cancer is a leading cause of death and despite many new drugs, a major diagnostic challenge remains knowing which drug will work best for a patient. A new class of drugs called immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment. However, current diagnostic methods (e.g. PDL1, MSI and TMB) do not accurately predict which patients will respond. Elephas is developing a diagnostic platform using small 3D Live Tumor Fragments (LTFs) from participants for accurate prediction of drug response with a focus on ICIs such as Pembrolizumab (Keytruda). These LTFs contain both tumor cells and infiltrating immune cells, which are critical in determining response to ICIs and other immunotherapies. In this observational clinical trial, 200 Non-Small Cell Lung Cancer (NSCLC) participants will be recruited and their actual clinical response to ICIs (using RECIST 1.1) will be compared to the platform's predictive Artificial Intelligence (AI) score that is based on RNA, clinical data, and 3D microscopy images. The sensitivity and specificity of the platform's score will be determined and compared to current diagnostic methods for ICIs like PDL1, MSI, and TMB.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

UCLA Medical Center, Los Angeles, California, United States

James M Stockman Cancer Institute, Frederick, Maryland, United States

New York Cancer & Blood Specialists, Shirley, New York, United States

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

Gabrail Cancer Center, Canton, Ohio, United States

JPS Health Network, Fort Worth, Texas, United States

Baylor Scott & White Research Institute, Temple, Texas, United States

Contact Details

Name: Fred Hausheer, MD, FACP

Affiliation: Elephas

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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