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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• Age ≥ 18 years at the time of consent.

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

‣ Subjects who are undiagnosed, have undergone imaging and are suspected to have Stage IV lung cancer.

⁃ Subjects with a previous Stage I, II, or III diagnosis of NSCLC, who are being re-biopsied due to suspected progression to metastatic disease.

⁃ 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.

⁃ Subjects who have a previous Stage IV/metastatic NSCLC diagnosis and have already received first line treatment.

• 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.

• 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.

Locations
United States
California
UCLA Medical Center
NOT_YET_RECRUITING
Los Angeles
Maryland
James M Stockman Cancer Institute
RECRUITING
Frederick
North Carolina
University of North Carolina at Chapel Hill
TERMINATED
Chapel Hill
New York
New York Cancer & Blood Specialists
NOT_YET_RECRUITING
Shirley
Ohio
Gabrail Cancer Center
TERMINATED
Canton
Texas
JPS Health Network
RECRUITING
Fort Worth
Baylor Scott & White Research Institute
RECRUITING
Temple
Contact Information
Primary
Catarina Costa
ClinicalTrials@elephas.com
609-955-4927
Time Frame
Start Date: 2023-01-31
Estimated Completion Date: 2026-12
Participants
Target number of participants: 200
Treatments
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.
Sponsors
Leads: Elephas

This content was sourced from clinicaltrials.gov

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