NCT03633006

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,298 (actual)
• Sponsor: Exact Sciences Corporation · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lung Cancer (Diagnosis)

Interventions

Type	Name	Description
OTHER	Blood Sample Collection	Subjects participating in the study will have blood drawn at enrollment. Additional blood samples may be collected at 12 months from enrollment.
OTHER	Blood Sample Collection	Subjects participating in the study will have blood drawn at enrollment. Additional blood samples may be collected at 12 months from enrollment if lung cancer has not been confirmed.
OTHER	Blood Sample Collection	Subjects participating in the study will have blood drawn at enrollment.

Timeline

• Start date: 2016-04-11
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2018-08-16
• Last updated: 2021-02-15

Locations

83 sites across 1 country: United States