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

February 12, 2021 updated by: Exact Sciences Corporation

2016-11: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1718

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Achieve Clinical Research
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Phoenix Medical Group
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Highlands Oncology Group
    • California
      • Newport Beach, California, United States, 92663
        • NewportNativeMD, Inc.
      • Palm Springs, California, United States, 92262
        • Palmtree Clinical Research, Inc.
    • Florida
      • Doral, Florida, United States, 33122
        • International Research Partners, LLC
      • Miami, Florida, United States, 33186
        • Clinical Trials of Florida, LLC
      • Ocala, Florida, United States, 34474
        • Sarkis Clinical Trials
      • Saint Petersburg, Florida, United States, 33707
        • Pasadena Center for Medical Research, Inc.
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
    • Iowa
      • Cedar Rapids, Iowa, United States, 52402
        • UnityPoint Health - St. Luke's Hospital
    • Maryland
      • Hagerstown, Maryland, United States, 21742
        • Meritus Center for Clinical Research
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic, Inc.
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Boone Hospital Center
    • Nebraska
      • Omaha, Nebraska, United States, 68178
        • Creighton University
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Pulmonary Ultimate Research Experience, LLC
    • New York
      • Manhasset, New York, United States, 11030
        • Northwell Health Physicians Pulmonary Medicine
      • New York, New York, United States, 10001
        • Gotham Cardiovascular Research, PC
    • Ohio
      • Milford, Ohio, United States, 45150
        • Clinical Trials Developers, Inc.
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16508
        • Chest Diseases of Northwestern PA
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Health Network
      • Pittsburgh, Pennsylvania, United States, 15243
        • Research Protocol Management Specialists
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Safe Harbor Clinical Research
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Anderson Pharmaceutical Research, LLC
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Charleston, South Carolina, United States, 29401
        • Charleston Research Institution
      • Mount Pleasant, South Carolina, United States, 29494
        • Clinical Research of Charleston
      • Spartanburg, South Carolina, United States, 29303
        • South Carolina Pharmaceutical Research
      • Union, South Carolina, United States, 29379
        • Union Pharmaceutical Research
    • Virginia
      • Richmond, Virginia, United States, 23225
        • Pulmonary Associates of Richmond, Inc.
    • Wisconsin
      • Waukesha, Wisconsin, United States, 53188
        • Prohealth Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
27 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Exact Sciences Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Laura Strong, Exact Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 6, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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