Clinical trial NCT05987189: Diagnostic Performance of Small RNA Blood Test in Patients Undergoing Follow-up Imaging After Positive Low Dose CT Screening for Cancer of the Lung
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"
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Lead sponsor: Hummingbird Diagnostics
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 2000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Objective
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Boston
country: United States
facility: Mass General Brigham
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Bronx
country: United States
facility: New York Health + Hospitals
state: New York
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Beaumont
country: United States
facility: Baptist Hospitals of Southeast Texas
state: Texas
city: Salt Lake City
country: United States
facility: University Of Utah Health
state: Utah
Study officials:
References: