Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program
The primary objective of this study is to establish a control population to assess performance of an investigational diagnostic test targeting lung neoplasms.
Checked against the public recordLast updated Feb 15, 2021 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- Exact Sciences Corporation
- Interventions being studied
- Other: Blood Sample Collection
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Achieve Clinical ResearchBirmingham, Alabama
- Phoenix Medical GroupPeoria, Arizona
- Highlands Oncology GroupSpringdale, Arkansas
- NewportNativeMD, Inc.Newport Beach, California
- Palmtree Clinical Research, Inc.Palm Springs, California
- International Research Partners, LLCDoral, Florida
- Clinical Trials of Florida, LLCMiami, Florida
- Sarkis Clinical TrialsOcala, Florida
- Sarasota Memorial HospitalSarasota, Florida
- Pasadena Center for Medical Research, Inc.St. Petersburg, Florida
- UnityPoint Health - St. Luke's HospitalCedar Rapids, Iowa
- Meritus Center for Clinical ResearchHagerstown, Maryland
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 15, 2021. Always confirm current availability with the study team.