Lung Cancer Clinical Trial
Diagnostic Performance of Small RNA Blood Test in Patients Undergoing Follow-up Imaging After Positive Low Dose CT Screening for Cancer of the Lung
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.
Full 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.
Eligibility 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
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There are 7 Locations for this study
Atlanta Georgia, 30342, United States More Info
Principal Investigator
Boston Massachusetts, 02115, United States More Info
Principal Investigator
Detroit Michigan, 48202, United States More Info
Principal Investigator
Bronx New York, 10461, United States More Info
Principal Investigator
Bronx New York, 10461, United States More Info
Principal Investigator
Durham North Carolina, 27710, United States More Info
Principal Investigator
Beaumont Texas, 77701, United States More Info
Contact
Contact
Principal Investigator
Salt Lake City Utah, 84112, United States More Info
Principal Investigator
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