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

Description

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

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Study Overview

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Study Details

Study overview

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.

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"

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

Condition
Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Atlanta

Northside Hospital, Atlanta, Georgia, United States, 30342

Boston

Mass General Brigham, Boston, Massachusetts, United States, 02115

Detroit

Henry Ford Health, Detroit, Michigan, United States, 48202

Bronx

Jacobi Medical Center, Bronx, New York, United States, 10461

Bronx

New York Health + Hospitals, Bronx, New York, United States, 10461

Durham

Duke University Health System, Durham, North Carolina, United States, 27710

Beaumont

Baptist Hospitals of Southeast Texas, Beaumont, Texas, United States, 77701

Salt Lake City

University Of Utah Health, Salt Lake City, Utah, United States, 84112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

50 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hummingbird Diagnostics,

Study Record Dates

2025-12