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

Lung Cancer Clinical Trial

Official title:

Diagnostic Performance of Small RNA Blood Test in Patients Undergoing Follow-up Imaging After Positive Low Dose CT Screening for Cancer of the Lung "Early Detection of Lung Cancer Based on Small RNA Signatures - Boston II"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05987189
• Other study ID #: Boston II
• Status: Recruiting
• Start date: October 18, 2023
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Hummingbird Diagnostics
• Contact: Kaja Tikk
• Phone: 4962219143355
• Email: ktikk[@]hb-dx.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	Northside Hospital	Atlanta	Georgia
United States	Baptist Hospitals of Southeast Texas	Beaumont	Texas
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	Henry Ford Health	Detroit	Michigan
United States	Duke University Health System	Durham	North Carolina
United States	University Of Utah Health	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Hummingbird Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Objective	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.	1 year