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

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: Completed
• Conditions: Healthy
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 1718

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarker Identification	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

• Sponsor: Exact Sciences Corporation
• Investigators: Study Director: Laura Strong, Exact Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2017
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: August 9, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID 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