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Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program (2016-11)

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ClinicalTrials.gov Identifier: NCT03628638
Recruitment Status : Completed
First Posted : August 14, 2018
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation

Tracking Information
First Submitted Date August 9, 2018
First Posted Date August 14, 2018
Last Update Posted Date February 15, 2021
Actual Study Start Date April 6, 2017
Actual Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 11, 2018)
Biomarker Identification [ Time Frame: 27 months ]
Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood to detect lung cancer
Original Primary Outcome Measures
 (submitted: August 9, 2018)
Biomarker Identification [ Time Frame: 27 months ]
To identify biomarkers for the detection of lung cancer
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
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.
Condition Healthy
Intervention Other: Blood Sample Collection
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.
Study Groups/Cohorts
  • Lung Cancer Screening Patients - No Nodules
    Subjects in an low dose CT screening program that present no nodules.
    Intervention: Other: Blood Sample Collection
  • 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
    Intervention: Other: Blood Sample Collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 6, 2020)
1718
Original Estimated Enrollment
 (submitted: August 9, 2018)
1500
Actual Study Completion Date January 31, 2021
Actual Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03628638
Other Study ID Numbers 2016-11
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (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.
Responsible Party Exact Sciences Corporation
Study Sponsor Exact Sciences Corporation
Collaborators Not Provided
Investigators
Study Director: Laura Strong Exact Sciences
PRS Account Exact Sciences Corporation
Verification Date February 2021