Blood Sample Collection in Subjects With Pulmonary Nodules or CT Suspicion of Lung Cancer or Pathologically Diagnosed Lung Cancer

Recruiting in Palo Alto (17 mi)

+82 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Exact Sciences Corporation

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Research Team

Laura Strong

Principal Investigator

Exact Sciences

Eligibility Criteria

Inclusion Criteria

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

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

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.

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Treatment Details

Interventions

Blood Sample Collection ()

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Pulmonary NodulesExperimental Treatment1 Intervention

Subject with pulmonary nodules will be enrolled, provide a blood sample and may be followed up to 2 years for nodule resolution. A second blood draw will be collected at 12 months.

Group II: Pathologically Confirmed CancerExperimental Treatment1 Intervention

Subject has pathologically confirmed lung cancer and is treatment naïve. Subject will be enrolled and provide a blood sample.

Group III: CT Suspicion of CancerExperimental Treatment1 Intervention

Subject with suspicion of lung cancer will provide a blood sample. Diagnostic information will be collected to confirm the final diagnosis.