This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05478538
Recruitment Status : Recruiting
First Posted : July 28, 2022
Last Update Posted : April 23, 2024
Sponsor:
Information provided by (Responsible Party):
Elephas

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Metastatic Non Small Cell Lung Cancer NSCLC Metastatic NSCLC - Non-Small Cell Lung Cancer Procedure: Core Needle or Forceps Biopsy

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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform (CYBRID-01)
Actual Study Start Date : January 31, 2023
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Stage IV or metastatic Non Small Cell Lung Cancer (NSCLC)

Subjects suspected of or diagnosed with Stage IV NSCLC and meet one of the following criteria:

  1. Subjects who are undiagnosed, have undergone imaging and are suspected to have Stage IV lung cancer.
  2. Subjects with a Stage I, II, or III diagnosis of NSCLC, who are being re-biopsied after imaging-confirmed progression to metastatic disease
  3. Subjects who have a confirmed diagnosis of NSCLC, and have undergone a SOC biopsy procedure and will undergo a separate procedure for the purposes of this study.
  4. Subjects who have a previous Stage IV/metastatic NSCLC diagnosis and have already received first line treatment.
 Procedure: Core Needle or Forceps Biopsy
Subjects must be clinically able, at investigator discretion, to undergo additional core needle or forceps biopsy passes during their biopsy. These additional biopsies may either be collected from the primary tumor or a metastatic site amenable to additional passes (e.g., liver or lymph nodes) per the clinician.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Sensitivity and Specificity of Cybrid Score for Predicting In-Vivo Clinical Response to Immune Checkpoint Inhibitors [ Time Frame: 3 years ]
    The ex-vivo prognostic accuracy of the Cybrid live tumor diagnostic platform will be determined using in-vivo RECIST 1.1 as the reference method.


Secondary Outcome Measures :
  1. Determine the Area Under the Receiver Operating Characteristic Curve (AUC) of Cybrid Score and Compare to the AUCs of Current FDA Approved Predictive Biomarkers PD-L1 and Tumor Mutation Burden (TMB) [ Time Frame: 3 years ]
    The AUC of Cybrid Score will be established with a clinically meaningful confidence interval and compared to the AUCs of established FDA approved biomarkers for predicting clinical response to ICIs.


Biospecimen Retention:   Samples With DNA
Fresh tissue sampling using core needle or forceps biopsy.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suspected of or diagnosed with metastatic non-small cell lung cancer (NSCLC).
Criteria

Subject Inclusion Criteria

  1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
  2. Age ≥ 18 years at the time of consent.

  3. Subjects suspected of or diagnosed with Stage IV/metastatic NSCLC and meet one of the following criteria:

    1. Subjects who are undiagnosed, have undergone imaging and are suspected to have Stage IV lung cancer.
    2. Subjects with a previous Stage I, II, or III diagnosis of NSCLC, who are being re-biopsied due to suspected progression to metastatic disease.
    3. Subjects who have a newly confirmed diagnosis of Stage IV NSCLC, have undergone a SOC biopsy procedure and will undergo a separate procedure for the purposes of this study prior to starting first line treatment.
    4. Subjects who have a previous Stage IV/metastatic NSCLC diagnosis and have already received first line treatment.
  4. Subjects must be clinically able, at investigator discretion, to undergo additional CNB or forceps biopsy passes during their biopsy. These additional biopsies may either be collected from the primary tumor or a metastatic site amenable to additional passes (e.g., liver or lymph nodes) per the clinician.
  5. Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy. All other subjects should have the biopsy performed before starting their next line of treatment.

Subject Exclusion Criteria

  1. Any patient for whom an extra biopsy might pose a clinical risk based on the discretion of the clinician.
  2. Any mental impairment that would render the patient unable to understand his/her participation in the study would disqualify the patient from consenting and participating.
  3. Subjects with an auto-immune disease that would render them ineligible for immune- oncology treatment.
  4. Immunocompromised subjects, and subjects known to be HIV positive and currently receiving antiretroviral therapy. NOTE: Patients known to be HIV positive, but without clinician evidence of an immunocompromised state, are eligible for this trial.
  5. Subjects who are enrolled or plan to be enrolled in a blinded oncology treatment trial are not eligible.
  6. Subjects who are pregnant are not eligible.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05478538


Contacts
Layout table for location contacts
Contact: Catarina Costa 609-955-4927 ClinicalTrials@elephas.com

Locations
Layout table for location information
United States, California
UCLA Medical Center Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Saima Chaabane       SChaabane@mednet.ucla.edu   
Principal Investigator: Fereidoun Abtin, MD         
United States, Maryland
James M Stockman Cancer Institute Not yet recruiting
Frederick, Maryland, United States, 21702
Contact: Ingrid Halvorson       IHalvorson@Frederick.health   
Principal Investigator: Heather Chalfin, MD         
United States, New York
New York Cancer & Blood Specialists Not yet recruiting
Shirley, New York, United States, 11967
Contact: Laura Parisi       lparisi@nycancer.com   
Principal Investigator: Richard Zuniga, MD         
United States, North Carolina
University of North Carolina at Chapel Hill Terminated
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Gabrail Cancer Center Terminated
Canton, Ohio, United States, 44718
United States, Texas
JPS Health Network Recruiting
Fort Worth, Texas, United States, 76104
Contact: April Bell       ABell01@jpshealth.org   
Principal Investigator: Paras Patel, MD         
Baylor Scott & White Research Institute Recruiting
Temple, Texas, United States, 76508
Contact: Lorie A Fares    254-724-2841    Lorie.Fares@BSWHealth.org   
Contact: Andrea G Mosko    254-724-2841    Andrea.Mosko@BSWHealth.org   
Principal Investigator: Alan Gowan, DO         
Sponsors and Collaborators
Elephas
Investigators
Layout table for investigator information
Study Director: Fred Hausheer, MD, FACP Elephas
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Elephas
ClinicalTrials.gov Identifier: NCT05478538    
Other Study ID Numbers: ELEP-2022-CYBRID-01
First Posted: July 28, 2022    Key Record Dates
Last Update Posted: April 23, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elephas:
Metastatic NSCLC
NSCLC
Non Small Cell Lung Cancer
Core needle biopsy
Live tumor fragments
Immunotherapy
 Immunotherapy prediction
3D culture
Ex vivo platform
Immune checkpoint inhibitors
Forceps biopsy
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms