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SLUHN 2016-64

A Study to Evaluate a Panel of Blood Biomarkers for Use in Patients Undergoing Evaluation for Lung Cancer, ONC-LN-04

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Leah Bryant, LPN
    484-526-7825

    leah.bryant@sluhn.org
  • Synopsis: The purpose of this research study is to evaluate an experimental blood test, known as the ONC-LN-04 Lung Test, for the detection of lung cancer. You are being asked to be in this study because you have an upcoming screening or have scheduled a lung biopsy and may meet the study requirements. Experimental tests, such as those used on the blood collected in this study are also known as “investigational.” This means the tests have not been approved by the U.S. Food and Drug Administration (FDA).
    In this study, the accuracy of these blood tests will be determined by comparing the results with other tests as determined by your study doctor.
    Your participation in this study will be limited to:

    • A single blood draw with the blood specimen sent to the Sponsor.
    • The disclosure of your screening results.
    • The disclosure of any biopsy or pathology reports resulting from the screening findings.
    • The disclosure of any treatment resulting from biopsy outcomes.
    • All disclosures will be sent to the Sponsor.
    • Signed written informed consent
    • Women or men age 21 years or older
    • History of smoking tobacco, either current or past
    • Willing and able to comply with study-related procedure
    • Willing and able to donate up to 30 mL of blood
    • Underwent one of the following
      • Recent LDCT with nodule 3 cm in largest diameter or smaller identified, leading to recommendation of ongoing management (may include further radiological screening, radiological surveillance at a later date, nodule biopsy and/or surgery)
      • Lung nodule 3 cm in largest diameter or smaller identified by other diagnostic modality (e.g., CT scan, PET scan) leading to recommendation of ongoing management (may include further radiological screening, radiological surveillance at a later date, nodule biopsy and/or surgery)
      • Received confirmed diagnosis of NSCLC and treatment-naïve (e.g., has not undergone surgical excision, chemotherapy or radiation therapy for this malignancy)
      • Underwent radiologic imaging at 1-2 years prior to enrollment with documented no growth and presumed benign 1-2 years post initial LDCT
    • In the view of the investigator, would be a candidate for bronchoscopy, biopsy or surgical excision which would provide a histopathology diagnosis OR for radiological surveillance for up to 2 years which would provide a presumed benign diagnosis
    • Willing to provide LDCT, other CT or PET scan, radiology, bronchoscopy, biopsy/surgery and histopathology results to the Sponsor
    • In the view of the investigator, subject is unable to comply with study-related procedures
    • In the view of the investigator, subject is not a candidate for:
      • Bronchoscopy, biopsy or surgical excision due to co-morbidities or other findings (e.g., COPD, emphysema, infectious disease, indwelling electronic device) OR
      • Ongoing radiological surveillance for up to 2 years due to co-morbidities, limited lifespan, or other findings
    • Subject is known to have current ongoing or recurrent lung cancer (prior history of lung cancer with documented no evidence of disease is acceptable)
    • Subject has history of any non-lung primary malignancy, with the exception of previously treated non-melanoma skin cancer or cervical cancer
    • As a result of current screening with a diagnosis of lung cancer, subject has had curative lung cancer surgery or systemic therapy that removed the current lung cancer pathology