Lung Cancer
Conditions
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.
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.
Interventions
DIAGNOSTIC_TESTmiLungDx
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.
Sponsors
Hummingbird Diagnostics
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective | 1 year | 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. |
Countries
United States
Contacts
Primary ContactKaja Tikk
Outcome results
None listed