The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens for use in assessing new biomarkers for the detection of neoplasms of the lung. Subjects will be men and women, 35 years of age and older, with a CT confirmed nodule measuring 6-30 mm.

Subjects with pulmonary nodules, a suspicion of lung cancer or pathologically confirmed, untreated lung cancer will be enrolled. Blood samples will be collected at enrollment and may be collected at 12 months for subjects with pulmonary nodules. Radiological and pathological data will be collected to confirm a cancer diagnosis or up to 2 years to assess nodule resolution.

Inclusion Criteria:

• All Subjects:

  1. Subject is male or female, 35 years of age or older.

  2. Subject has at least one CT confirmed 6-30 mm nodule.

  3. Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

     Suspicion of Cancer Subjects:

  4. Subject has CT suspicion of lung cancer and is scheduled for biopsy or other diagnostic procedure.

Pathologically Confirmed Cancer Subjects:

4. Subject has pathologically confirmed lung cancer and is treatment naïve.

Pulmonary Nodule Subjects:

4. Subject has a recent (within 90 days of enrollment) CT radiological diagnosis of pulmonary nodule(s) without a scheduled biopsy/diagnostic procedure (other than CT or PET/CT).

Exclusion Criteria:

• All Subjects

  1. CT with IV contrast within 1 day [or 24 hours] of blood collection.

  2. Prior history of cancer within the past 5 years except for non-melanoma skin cancer. For subjects with suspicion of lung cancer who may have a concurrent work-up for another primary cancer, the non-lung cancer primary must be ruled out prior to enrollment.

  3. Prior removal of the lung, excluding percutaneous lung biopsy.

  4. Treatment (e.g., surgical resection, radiofrequency ablation) for pulmonary nodules prior to blood sample collection for this trial.

  5. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

     Pathologically Confirmed Cancer Subjects:

  6. Biopsy within 7 days prior to blood collection.

  7. Unresolved bleeding as a result of biopsy at the time of enrollment.

Approximately 3,250 subjects will be enrolled in this study. Subjects will be men and women, 35 years of age or older, with a CT confirmed nodule measuring 6-30 mm. Subjects will be enrolled into one of three groups: CT suspicion of lung cancer who are scheduled for biopsy/other diagnostic procedure; pathologically confirmed lung cancer that are treatment naïve; or recent positive CT showing pulmonary nodule(s) without a scheduled biopsy/diagnostic procedure.

Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol, informed consent form, and clinical study report will also be shared.

Data will be available from 2 years and ending 4 years after publication. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.

Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requesors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research. Data will be available between 2 and 4 years after publication through the Sponsor.