Diagnostic Performance of Small RNA Blood Test in Patients Undergoing Follow-up Imaging After Positive Low Dose CT Screening for Cancer of the Lung
1 other identifier
observational
2,000
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2023
Typical duration for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedStudy Start
First participant enrolled
October 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJanuary 16, 2024
January 1, 2024
12 months
April 26, 2023
January 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Objective
The study is a prospective, longitudinal, observational study to evaluate the performance of a novel diagnostic test for early-stage lung cancer. The primary endpoint is to detect the presence or absence of lung cancer, as determined by all follow-up imaging, and pathological data obtained throughout the duration of the study.
1 year
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
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
The Bronx, New York, 10461, United States
New York Health + Hospitals
The 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
Biospecimen
\*Blood sample (2x2,5 ml blood in PAXgene® tubes, 1x10 ml Streck® RNA Complete BCT CE blood, 1x10 ml Streck® Cell-free DNA BCT CE blood)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2023
First Posted
August 14, 2023
Study Start
October 18, 2023
Primary Completion
October 1, 2024
Study Completion
December 1, 2025
Last Updated
January 16, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share