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
11
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
11 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
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
September 30, 2026
September 1, 2026
3.5 years
April 26, 2023
September 25, 2026
Conditions
Keywords
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
Study Arms (1)
Participants undergoing diagnostic evaluation following positive LDCT screening
Participants undergoing further diagnostic evaluation following a positive LDCT lung cancer screening result. A blood sample is collected at enrollment, prior to any invasive diagnostic procedure or treatment, for evaluation of a small RNA-based lung cancer assay. Participants are followed to determine the final clinical diagnosis.
Interventions
At study enrollment, a blood sample is collected prior to any invasive diagnostic procedure or treatment. A small RNA-based lung cancer assay is performed on the collected blood sample for research purposes. Assay results are not returned to participants or investigators and are not used for clinical decision-making.
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 (11)
Northside Hospital
Atlanta, Georgia, 30342, United States
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02108, United States
Mass General Hospital
Boston, Massachusetts, 02115, United States
UMass Chan Medical School/UMass Memorial Health
Worcester, Massachusetts, 01655, United States
Henry Ford Health
Detroit, Michigan, 48202, United States
New York Health + Elmhurst Hospitals
Queens, New York, 10461, United States
Jacobi Medical Center
The Bronx, New York, 10461, United States
Clinical Research Associates of Central PA
DuBois, Pennsylvania, 15801, 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), dried blood spot (MITRA device)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- 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 (Estimated)
May 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
September 30, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share