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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

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.

Condition or disease Intervention/treatment
Healthy Other: Blood Sample Collection

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.

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Study Type : Observational
Actual Enrollment : 1718 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 2016-11: Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program
Actual Study Start Date : April 6, 2017
Actual Primary Completion Date : January 31, 2021
Actual Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Lung Cancer Screening Patients - No Nodules
Subjects in an low dose CT screening program that present no nodules.
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.

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
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.




Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
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.


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03628638


Locations
Show Show 31 study locations
Sponsors and Collaborators
Exact Sciences Corporation
Investigators
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Study Director: Laura Strong Exact Sciences
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Responsible Party: Exact Sciences Corporation
ClinicalTrials.gov Identifier: NCT03628638    
Other Study ID Numbers: 2016-11
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 2021
Individual Participant Data (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
Informed Consent Form (ICF)
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No