Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program
2016-11
2016-11: Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program
1 other identifier
observational
1,718
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2017
Longer than P75 for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 6, 2017
CompletedFirst Submitted
Initial submission to the registry
August 9, 2018
CompletedFirst Posted
Study publicly available on registry
August 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2021
CompletedFebruary 15, 2021
February 1, 2021
3.8 years
August 9, 2018
February 12, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Biomarker Identification
Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood to detect lung cancer
27 months
Study Arms (2)
Lung Cancer Screening Patients - No Nodules
Subjects in an low dose CT screening program that present no nodules.
Lung Cancer Screening Patients - Nodules
Subjects in an low dose CT screening program that present nodules. Additional follow-up data will be collected for up to 12 months and an additional blood sample collected
Interventions
Subjects participating in the study will have blood sample collected at enrollment. . For any subjects scheduled for a 12 month follow-up, additional blood samples will be collected at 12 months from enrollment.
Eligibility Criteria
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.
You may qualify if:
- Subject is male or female, 50 years of age or older.
- Subject meets one of two lung cancer screening criteria below.
- 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).
- 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.
You may not qualify if:
- 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).
- Prior history of cancer within the past 5 years except for non-melanoma skin cancer.
- Prior removal of the lung, excluding percutaneous lung biopsy.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Achieve Clinical Research
Birmingham, Alabama, 35216, United States
Phoenix Medical Group
Peoria, Arizona, 85381, United States
Highlands Oncology Group
Springdale, Arkansas, 72762, United States
NewportNativeMD, Inc.
Newport Beach, California, 92663, United States
Palmtree Clinical Research, Inc.
Palm Springs, California, 92262, United States
International Research Partners, LLC
Doral, Florida, 33122, United States
Clinical Trials of Florida, LLC
Miami, Florida, 33186, United States
Sarkis Clinical Trials
Ocala, Florida, 34474, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Pasadena Center for Medical Research, Inc.
St. Petersburg, Florida, 33707, United States
UnityPoint Health - St. Luke's Hospital
Cedar Rapids, Iowa, 52402, United States
Meritus Center for Clinical Research
Hagerstown, Maryland, 21742, United States
Lahey Clinic, Inc.
Burlington, Massachusetts, 01805, United States
Boone Hospital Center
Columbia, Missouri, 65201, United States
Creighton University
Omaha, Nebraska, 68178, United States
Pulmonary Ultimate Research Experience, LLC
Toms River, New Jersey, 08755, United States
Northwell Health Physicians Pulmonary Medicine
Manhasset, New York, 11030, United States
Gotham Cardiovascular Research, PC
New York, New York, 10001, United States
Clinical Trials Developers, Inc.
Milford, Ohio, 45150, United States
Chest Diseases of Northwestern PA
Erie, Pennsylvania, 16508, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212, United States
Research Protocol Management Specialists
Pittsburgh, Pennsylvania, 15243, United States
Safe Harbor Clinical Research
East Providence, Rhode Island, 02914, United States
Anderson Pharmaceutical Research, LLC
Anderson, South Carolina, 29621, United States
Charleston Research Institution
Charleston, South Carolina, 29401, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Clinical Research of Charleston
Mt. Pleasant, South Carolina, 29494, United States
South Carolina Pharmaceutical Research
Spartanburg, South Carolina, 29303, United States
Union Pharmaceutical Research
Union, South Carolina, 29379, United States
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, 23225, United States
ProHealth Care
Waukesha, Wisconsin, 53188, United States
Biospecimen
Residual blood samples may be used for further analysis and future research. Samples may be stored for up to 20 years. These blood samples will be de-identified.
Study Officials
- STUDY DIRECTOR
Laura Strong
Exact Sciences
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2018
First Posted
August 14, 2018
Study Start
April 6, 2017
Primary Completion
January 31, 2021
Study Completion
January 31, 2021
Last Updated
February 15, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- Data will be available from 2 years and ending 4 years after publication. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.
- Access Criteria
- Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research. Data will be available between 2 and 4 years after publication through the Sponsor.
Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol, informed consent form, and clinical study report will also be shared.