Purpose

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.

Condition

Eligibility

Eligible Ages
Over 35 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All Subjects:
  • 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.

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
  • CT with IV contrast within 1 day [or 24 hours] of blood collection.
  • 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.
  • Prior removal of the lung, excluding percutaneous lung biopsy.
  • Treatment (e.g., surgical resection, radiofrequency ablation) for pulmonary nodules prior to blood sample collection for this trial.
  • 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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Pulmonary Nodules 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.
  • 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.
CT Suspicion of Cancer Subject with suspicion of lung cancer will provide a blood sample. Diagnostic information will be collected to confirm the final diagnosis.
  • 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.
Pathologically Confirmed Cancer Subject has pathologically confirmed lung cancer and is treatment naïve. Subject will be enrolled and provide a blood sample.
  • Other: Blood Sample Collection
    Subjects participating in the study will have blood drawn at enrollment.

Recruiting Locations

University of Texas Medical Branch
Galveston, Texas 77555
Contact:
Rochelle Simmons
409-772-5503
rrsimmon@utmb.edu

More Details

NCT ID
NCT03633006
Status
Recruiting
Sponsor
Exact Sciences Corporation

Study Contact

Alexandra Massoud
amassoud@exactsciences.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.