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NCT05987189 | RECRUITING | Lung Cancer

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

Condition or disease

Lung Cancer

Intervention/treatment

miLungDx

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 Type : OBSERVATIONAL
Estimated Enrollment : 2000 participants
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"
Actual Study Start Date : 2023-10-18
Estimated Primary Completion Date : 2024-10
Estimated Study Completion Date : 2025-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Diagnostic Performance of Small RNA Blood Test in Patients Undergoing Follow-up Imaging After Positive Low Dose CT Screening for Cancer of the Lung

Location Details

NCT05987189

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Georgia

Northside Hospital

Atlanta, Georgia, United States, 30342

RECRUITING

United States, Massachusetts

Mass General Brigham

Boston, Massachusetts, United States, 02115

RECRUITING

United States, road cancer

Henry Ford Health

Detroit, road cancer, United States, 48202

RECRUITING

United States, New York

Jacobi Medical Center

The Bronx, New York, United States, 10461

RECRUITING

United States, New York

New York Health + Hospitals

The Bronx, New York, United States, 10461

RECRUITING

United States, North Carolina

Duke University Health System

Durham, North Carolina, United States, 27710

RECRUITING

United States, Texas

Baptist Hospitals of Southeast Texas

Beaumont, Texas, United States, 77701

RECRUITING

United States, Utah

University Of Utah Health

Salt Lake City, Utah, United States, 84112