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

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT05987189
• Lead Sponsor: Hummingbird Diagnostics

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.

Detailed Description

The study is a prospective, longitudinal, observational study to evaluate the performance of a novel diagnostic test for early-stage lung cancer.

Study duration: Expected patient enrollment to be completed within 12 months after study initiation. Patients will be followed for a minimum of 12 months from the date of enrollment. The study duration is approximately 2 years.

Participant duration: The day of blood collection. Participants will follow their regular standard of care schedule as recommended by existing guidelines; no extra visits are planned. Follow up data will be obtained from the electronic medical record within at least 12 months of follow-up period.

Study Timeline

• Study First Submitted: 2023-04-26
• Study First Submitted QC: 2023-08-09
• Study First Posted: 2023-08-14
• Study Start: 2023-10-18
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-16
• Primary Completion: 2024-10
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Objective	1 year	The study is a prospective, longitudinal, observational study to evaluate the performance of a novel diagnostic test for early-stage lung cancer. The primary endpoint is to detect the presence or absence of lung cancer, as determined by all follow-up imaging, and pathological data obtained throughout the duration of the study.

Trial Locations

Locations (8)

Northside Hospital; 🇺🇸 Atlanta, Georgia, United States

Mass General Brigham; 🇺🇸 Boston, Massachusetts, United States

Jacobi Medical Center; 🇺🇸 Bronx, New York, United States

New York Health + Hospitals; 🇺🇸 Bronx, New York, United States

Duke University Health System; 🇺🇸 Durham, North Carolina, United States

Henry Ford Health; 🇺🇸 Detroit, Michigan, United States

Baptist Hospitals of Southeast Texas; 🇺🇸 Beaumont, Texas, United States

University Of Utah Health; 🇺🇸 Salt Lake City, Utah, United States