RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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"

Quick Facts

Study Start:2023-10-18
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05987189

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.

Ages Eligible for Study:50 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult male and female patients, aged 50 to 80 years
  2. * 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
  3. * Has undergone LD-CT screening exam within last 90 days and allows for blood sampling within this period
  4. * Subject may not have undergone any invasive diagnostic procedure in relation to the suspicious nodule
  5. * Able and willing to provide informed consent
  1. * Prior history of diagnosed lung cancer
  2. * History of gastrointestinal, hematological, breast, thyroid, and genitourinary cancer within the past 10 years
  3. * Active infectious diseases, such blood borne viral diseases (e.g. AIDS, hepatitis)
  4. * Immunosuppressive medication
  5. * Deemed not able to participate in the study by the investigator

Contacts and Locations

Study Contact

Kaja Tikk
CONTACT
4962219143355
ktikk@hb-dx.com

Study Locations (Sites)

Northside Hospital
Atlanta, Georgia, 30342
United States
Mass General Brigham
Boston, Massachusetts, 02115
United States
Henry Ford Health
Detroit, Michigan, 48202
United States
Jacobi Medical Center
Bronx, New York, 10461
United States
New York Health + Hospitals
Bronx, New York, 10461
United States
Duke University Health System
Durham, North Carolina, 27710
United States
Baptist Hospitals of Southeast Texas
Beaumont, Texas, 77701
United States
University Of Utah Health
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: Hummingbird Diagnostics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-18
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-10-18
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Lung Cancer