Recruiting

Observational StudyDiagnostic Performance of Small RNA Blood Test in Patients Undergoing Follow-up Imaging After Positive Low Dose CT Screening for Cancer of the Lung

Sponsor:

Hummingbird Diagnostics

Code:

NCT05987189

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

miLungDx

Study Details

Brief summary:

2,000 individuals, aged 50-80 who have received a lung-RADS category 3 or 4 result on a LDCT screening study and who are scheduled for follow-up diagnostic imaging study, biopsy, clinical consultation or surgical appointment at one of the participating hospitals.

Conditions

Lung Cancer

Study ID

NCT05987189

Start date

Oct 18, 2023

Status verified date

Jan, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Oct, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Adult male and female patients, aged 50 to 80 years
Received a lung RADS category 3 or 4 finding on a LDCT screening exam (first or subsequent) and are referred to undergo further diagnostic procedures for the detection of lung cancer
Has undergone LD-CT screening exam within last 90 days and allows for blood sampling within this period
Subject may not have undergone any invasive diagnostic procedure in relation to the suspicious nodule
Able and willing to provide informed consent

Exclusion Criteria:

Prior history of diagnosed lung cancer
History of gastrointestinal, hematological, breast, thyroid, and genitourinary cancer within the past 10 years
Active infectious diseases, such blood borne viral diseases (e.g. AIDS, hepatitis)
Immunosuppressive medication
Deemed not able to participate in the study by the investigator

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Interventions

miLungDx

At study enrollment a blood sample will be drawn prior to any invasive diagnostic study or treatment. On this blood sample a novel lung cancer test relying on small RNA signatures will be performed and evaluated.

Primary outcome measure

Primary Objective [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Kaja Tikk

4962219143355 ktikk@hb-dx.com

Locations

Northside Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Lia Adderley

404-236-8336 lia.adderley@northside.com

Principal Investigator:

Howard Silverboard, MD

Mass General Brigham

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Alexandra Kunen

617-643-5886 akunen@mgh.harvard.edu

Principal Investigator:

Milena Petranovic, MD

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Marie Tombrillo

msauve1@hfhs.org

Principal Investigator:

Michael Simoff, MD

Jacobi Medical Center

Recruiting

Bronx, New York, United States, 10461

Contacts

Raven Dwyer

dwyerr1@nychh.org

Principal Investigator:

Malika Pradhan, MD

New York Health + Hospitals

Recruiting

Bronx, New York, United States, 10461

Contacts

Kanwal Latif

347-210-4279 latifk@nychhc.org

Principal Investigator:

Muhammad Perwaiz, MD

Duke University Health System

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Elizabeth Mary Luck

919-684-7752 mary.luck@duke.edu

Principal Investigator:

Edwards Patz, MD

Baptist Hospitals of Southeast Texas

Recruiting

Beaumont, Texas, United States, 77701

Principal Investigator:

Ernest Hymel, MD

University Of Utah Health

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Robyn Barrus

801-581-5811 Robyn.Barrus@hsc.utah.edu

Principal Investigator:

Chakravarthy Reddy, MD

More Information

Sponsor

Hummingbird Diagnostics

Last update posted

Jan 16, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hummingbird Diagnostics on 2024-01-16.