Trial 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
NCT ID:
NCT05987189
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
miLungDx
Description:
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.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
50 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Northside Hospital
Address:
City:
Atlanta
Zip:
30342
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lia Adderley
Phone:
404-236-8336
Email:
lia.adderley@northside.com
Investigator:
Last name:
Howard Silverboard, MD
Email:
Principal Investigator
Facility:
Name:
Mass General Brigham
Address:
City:
Boston
Zip:
02115
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alexandra Kunen
Phone:
617-643-5886
Email:
akunen@mgh.harvard.edu
Investigator:
Last name:
Milena Petranovic, MD
Email:
Principal Investigator
Facility:
Name:
Henry Ford Health
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marie Tombrillo
Email:
msauve1@hfhs.org
Investigator:
Last name:
Michael Simoff, MD
Email:
Principal Investigator
Facility:
Name:
Jacobi Medical Center
Address:
City:
Bronx
Zip:
10461
Country:
United States
Status:
Recruiting
Contact:
Last name:
Raven Dwyer
Email:
dwyerr1@nychh.org
Investigator:
Last name:
Malika Pradhan, MD
Email:
Principal Investigator
Facility:
Name:
New York Health + Hospitals
Address:
City:
Bronx
Zip:
10461
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kanwal Latif
Phone:
347-210-4279
Email:
latifk@nychhc.org
Investigator:
Last name:
Muhammad Perwaiz, MD
Email:
Principal Investigator
Facility:
Name:
Duke University Health System
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elizabeth Mary Luck
Phone:
919-684-7752
Email:
mary.luck@duke.edu
Investigator:
Last name:
Edwards Patz, MD
Email:
Principal Investigator
Facility:
Name:
Baptist Hospitals of Southeast Texas
Address:
City:
Beaumont
Zip:
77701
Country:
United States
Status:
Recruiting
Contact:
Last name:
Samantha Blevins
Contact backup:
Last name:
Sarah Morris
Investigator:
Last name:
Ernest Hymel, MD
Email:
Principal Investigator
Facility:
Name:
University Of Utah Health
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Robyn Barrus
Phone:
801-581-5811
Email:
Robyn.Barrus@hsc.utah.edu
Investigator:
Last name:
Chakravarthy Reddy, MD
Email:
Principal Investigator
Start date:
October 18, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Hummingbird Diagnostics
Agency class:
Industry
Source:
Hummingbird Diagnostics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05987189
