Clinical trial NCT03628638: Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program
Official title: 2016-11: Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
First posted: 2018-08-14
Enrollment: 1718
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be men and women, 50 years of age or older. Subjects will be participating in a lung cancer screening program at the time of enrollment.

Brief summary: The primary objective of this study is to establish a control population to assess performance of an investigational diagnostic test targeting lung neoplasms.

Detailed description: Subjects will be participating in a lung cancer screening program at enrollment. Subjects will have a blood sample collected within 60 days of a low-dose CT scan (LDCT). Subjects with nodules present on the LDCT or subjects with a clean LDCT scheduled for a 12-month follow-up may have another blood draw at 12 months.

Eligibility criteria: Inclusion Criteria:

1. Subject is male or female, 50 years of age or older.
2. Subject meets one of two lung cancer screening criteria below.

   1. Subject is a candidate for LDCT lung cancer screening and is scheduled for a baseline LDCT scan. There may be circumstances when a patient cannot have an LDCT scan (e.g., due to insurance issues). In these cases, it is allowable for a patient to have a CT scan in order to meet the inclusion criteria. OR
   2. Subject has had previous LDCT scan(s) for lung cancer screening and the most recent LDCT scan prior to enrollment is negative for pulmonary nodules (Lung-RADS category 1, no nodules).
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.

Exclusion Criteria:

1. Subjects with pulmonary nodules on the most recent LDCT scan prior to enrollment (Lung-RADS category 1 nodules with specific calcifications such as complete, central, popcorn, concentric rings and fat containing nodules are excluded).
2. Prior history of cancer within the past 5 years except for non-melanoma skin cancer.
3. Prior removal of the lung, excluding percutaneous lung biopsy.
4. 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.

Primary outcomes:
measure: Biomarker Identification
timeFrame: 27 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research
state: Alabama
city: Peoria
country: United States
facility: Phoenix Medical Group
state: Arizona
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Newport Beach
country: United States
facility: NewportNativeMD, Inc.
state: California
city: Palm Springs
country: United States
facility: Palmtree Clinical Research, Inc.
state: California
city: Doral
country: United States
facility: International Research Partners, LLC
state: Florida
city: Miami
country: United States
facility: Clinical Trials of Florida, LLC
state: Florida
city: Ocala
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Saint Petersburg
country: United States
facility: Pasadena Center for Medical Research, Inc.
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Cedar Rapids
country: United States
facility: UnityPoint Health - St. Luke's Hospital
state: Iowa
city: Hagerstown
country: United States
facility: Meritus Center for Clinical Research
state: Maryland
city: Burlington
country: United States
facility: Lahey Clinic, Inc.
state: Massachusetts
city: Columbia
country: United States
facility: Boone Hospital Center
state: Missouri
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: Toms River
country: United States
facility: Pulmonary Ultimate Research Experience, LLC
state: New Jersey
city: Manhasset
country: United States
facility: Northwell Health Physicians Pulmonary Medicine
state: New York
city: New York
country: United States
facility: Gotham Cardiovascular Research, PC
state: New York
city: Milford
country: United States
facility: Clinical Trials Developers, Inc.
state: Ohio
city: Erie
country: United States
facility: Chest Diseases of Northwestern PA
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Protocol Management Specialists
state: Pennsylvania
city: East Providence
country: United States
facility: Safe Harbor Clinical Research
state: Rhode Island
city: Anderson
country: United States
facility: Anderson Pharmaceutical Research, LLC
state: South Carolina
city: Charleston
country: United States
facility: Charleston Research Institution
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Mount Pleasant
country: United States
facility: Clinical Research of Charleston
state: South Carolina
city: Spartanburg
country: United States
facility: South Carolina Pharmaceutical Research
state: South Carolina
city: Union
country: United States
facility: Union Pharmaceutical Research
state: South Carolina
city: Richmond
country: United States
facility: Pulmonary Associates of Richmond, Inc.
state: Virginia
city: Waukesha
country: United States
facility: ProHealth Care
state: Wisconsin
Study officials:
affiliation: Exact Sciences
name: Laura Strong
role: STUDY_DIRECTOR
References: