Blood Sample Collection in Subjects With Pulmonary Nodules or CT Suspicion of Lung Cancer or Pathologically Diagnosed Lung Cancer

The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens for use in assessing new biomarkers for the detection of neoplasms of the lung. Subjects will be men and women, 35 years of age and older, with a CT confirmed nodule measuring 6-30 mm.

Study Overview

• Status: Completed
• Conditions: Lung Cancer (Diagnosis)
• Intervention / Treatment: Other: Blood Sample Collection; Other: Blood Sample Collection; Other: Blood Sample Collection

Detailed Description

Subjects with pulmonary nodules, a suspicion of lung cancer or pathologically confirmed, untreated lung cancer will be enrolled. Blood samples will be collected at enrollment and may be collected at 12 months for subjects with pulmonary nodules. Radiological and pathological data will be collected to confirm a cancer diagnosis or up to 2 years to assess nodule resolution.

• Study Type: Observational
• Enrollment (Actual): 3298

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
  • California
    • Newport Beach, California, United States, 92663
      • Newport NativeMD
    • Palm Springs, California, United States, 92262
      • Palmtree Clinical Research, INC
    • Palo Alto, California, United States, 94304
      • Palo Alto Veterans Health Care
    • Upland, California, United States, 91786
      • Premier Medical Group
  • Florida
    • Cutler Bay, Florida, United States, 33157
      • American Research Institute, INC
    • Doral, Florida, United States, 33122
      • International Research Partners, LLC
    • Jupiter, Florida, United States, 33458
      • Jupiter Medical Center
    • Kissimmee, Florida, United States, 34741
      • Pulmonary Disease Specialists
    • Leesburg, Florida, United States, 34748
      • Medical Research of Central Florida, LLC
    • Miami, Florida, United States, 33186
      • Clinical Trials of Florida, LLC
    • Miami, Florida, United States, 33122
      • Future Clinical Research
    • Miami, Florida, United States, 33125
      • University of Miami Miller School of Medicine
    • Miami, Florida, United States, 33130
      • Orcinova AMS Research
    • Miami, Florida, United States, 33130
      • Sunrise Research Institute, Inc
    • Miami, Florida, United States, 33144
      • American Research Medical Group
    • Miami, Florida, United States, 33155
      • Health and Life Research Institute, LLC
    • Miami, Florida, United States, 33175
      • Care Research Center
    • Miami Gardens, Florida, United States, 33169
      • AMPM Research Clinic
    • Saint Petersburg, Florida, United States, 33704
      • Coastal Pulmonary and Critical Care, PLC
    • Saint Petersburg, Florida, United States, 33707
      • Pasadena Center for Medical Research, Inc
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital Clinical Research Center
    • Winter Park, Florida, United States, 32789
      • Florida Pulmonary Research Institute, LLC
    • Winter Park, Florida, United States, 32789
      • Pulmonary Care Research Group, PA
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Healthcare, Inc.
    • Buford, Georgia, United States, 30519
      • Gwinnett Research Institute, LLC
    • Columbus, Georgia, United States, 60631
      • Columbus Regional Research Institute
    • Lawrenceville, Georgia, United States, 30046
      • Gwinnett Biomedical Research
    • Marietta, Georgia, United States, 30060
      • DC Research Work
    • Rincon, Georgia, United States, 31326
      • Southeast Lung Associates Research
  • Idaho
    • Nampa, Idaho, United States, 83686
      • Saltzer Medical Group
  • Illinois
    • Champaign, Illinois, United States, 61820
      • PMG Research of Christie Clinic
    • Chicago, Illinois, United States, 60631
      • Medical and Procedural Specialists of Illinois, LLC
    • Maywood, Illinois, United States, 60153
      • Loyola University Chicago
  • Indiana
    • Anderson, Indiana, United States, 46011
      • Community Hospital of Anderson and Madison County, Inc.
  • Kansas
    • Augusta, Kansas, United States, 67010
      • Heartland Research Associates, LLC-An AMR Company
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University School of Medicine
    • Hagerstown, Maryland, United States, 21742
      • Meritus Center for Clinical Research
    • Hollywood, Maryland, United States, 20636
      • MedStar Shah Medical Group
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic, Inc
    • Newton, Massachusetts, United States, 02462
      • Newton-Wellesley Hospital
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Somnos Laboratories
    • Omaha, Nebraska, United States, 68178
      • Creighton University
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Virtua Health, Inc
    • Toms River, New Jersey, United States, 08755
      • Pulmonary Ultimate Research Experience, LLC (PURE, LLC)
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College MC-91
    • Jamaica, New York, United States, 11418
      • Jamaica Hospital Medical Center
    • New Hyde Park, New York, United States, 11040
      • Northwell Health
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • American Health Research, LLC
    • Gastonia, North Carolina, United States, 28054
      • Clinical Research of Gastonia
    • Gastonia, North Carolina, United States, 28054
      • Gastonia Pharmaceutical Research
    • Greensboro, North Carolina, United States, 27403
      • Pulmonix, LLC
    • Hickory, North Carolina, United States, 28601
      • Hickory Research Center DBA Research Carolina of Hickory
    • New Bern, North Carolina, United States, 28562
      • Coastal Carolina Health Care
    • Rocky Mount, North Carolina, United States, 27804
      • PMG Research of Rocky Mount, LLC
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington, LLC
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Milford, Ohio, United States, 45150
      • Clinical Trial Developers, Inc.
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • OK Clinical Research, LLC
  • Oregon
    • Portland, Oregon, United States, 97220
      • The Oregon Clinic, PC
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16508
      • Chest Diseases of Northwestern PA
    • Pittsburgh, Pennsylvania, United States
      • 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, 29401
      • Charletson Research Institute
    • Charleston, South Carolina, United States, 29425
      • The Medical University of South Carolina
    • Gaffney, South Carolina, United States, 29340
      • VitaLink Research--Gaffney (Gaffney Pharmaceutical Research, LLC)
    • Mount Pleasant, South Carolina, United States, 29464
      • Clinical Research of Charleston
    • Rock Hill, South Carolina, United States, 29732
      • Clinical Research of Rock Hill
    • Rock Hill, South Carolina, United States, 29732
      • VitaLink Research-Rock Hill
    • Spartanburg, South Carolina, United States, 29303
      • South Carolina Pharmaceutical Research, LLC
    • Union, South Carolina, United States, 29379
      • Union Pharmaceutical Research
  • Texas
    • Cypress, Texas, United States, 77429
      • Houston Pulmonary Sleep and Allergy Associates
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch
    • Laredo, Texas, United States, 78041
      • Envision Cancer Care, LLC
    • The Woodlands, Texas, United States, 77380
      • Renovatio Clinical Consultants, LLC
    • The Woodlands, Texas, United States, 77380
      • Renovatio Clinical
  • Virginia
    • Richmond, Virginia, United States, 23225
      • Pulmonary Associates of Richmond
  • Washington
    • Bellevue, Washington, United States, 98004
      • Overlake Hospital Medical Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin School of Medicine and Public Health
    • Madison, Wisconsin, United States, 53705
      • William S. Middleton Memorial Veterans Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Approximately 3,250 subjects will be enrolled in this study. Subjects will be men and women, 35 years of age or older, with a CT confirmed nodule measuring 6-30 mm. Subjects will be enrolled into one of three groups: CT suspicion of lung cancer who are scheduled for biopsy/other diagnostic procedure; pathologically confirmed lung cancer that are treatment naïve; or recent positive CT showing pulmonary nodule(s) without a scheduled biopsy/diagnostic procedure.

Description

Inclusion Criteria:

• All Subjects:

  1. Subject is male or female, 35 years of age or older.
  2. Subject has at least one CT confirmed 6-30 mm nodule.

  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.

     Suspicion of Cancer Subjects:

  4. Subject has CT suspicion of lung cancer and is scheduled for biopsy or other diagnostic procedure.

Pathologically Confirmed Cancer Subjects:

4. Subject has pathologically confirmed lung cancer and is treatment naïve.

Pulmonary Nodule Subjects:

4. Subject has a recent (within 90 days of enrollment) CT radiological diagnosis of pulmonary nodule(s) without a scheduled biopsy/diagnostic procedure (other than CT or PET/CT).

Exclusion Criteria:

• All Subjects

  1. CT with IV contrast within 1 day [or 24 hours] of blood collection.
  2. Prior history of cancer within the past 5 years except for non-melanoma skin cancer. For subjects with suspicion of lung cancer who may have a concurrent work-up for another primary cancer, the non-lung cancer primary must be ruled out prior to enrollment.
  3. Prior removal of the lung, excluding percutaneous lung biopsy.
  4. Treatment (e.g., surgical resection, radiofrequency ablation) for pulmonary nodules prior to blood sample collection for this trial.

  5. 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.

     Pathologically Confirmed Cancer Subjects:

  6. Biopsy within 7 days prior to blood collection.
  7. Unresolved bleeding as a result of biopsy at the time of enrollment.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pulmonary Nodules; Subject with pulmonary nodules will be enrolled, provide a blood sample and may be followed up to 2 years for nodule resolution. A second blood draw will be collected at 12 months.	Other: Blood Sample Collection; Subjects participating in the study will have blood drawn at enrollment.; Other: Blood Sample Collection; Subjects participating in the study will have blood drawn at enrollment. Additional blood samples may be collected at 12 months from enrollment.; Other: Blood Sample Collection; Subjects participating in the study will have blood drawn at enrollment. Additional blood samples may be collected at 12 months from enrollment if lung cancer has not been confirmed.
CT Suspicion of Cancer; Subject with suspicion of lung cancer will provide a blood sample. Diagnostic information will be collected to confirm the final diagnosis.	Other: Blood Sample Collection; Subjects participating in the study will have blood drawn at enrollment.; Other: Blood Sample Collection; Subjects participating in the study will have blood drawn at enrollment. Additional blood samples may be collected at 12 months from enrollment.; Other: Blood Sample Collection; Subjects participating in the study will have blood drawn at enrollment. Additional blood samples may be collected at 12 months from enrollment if lung cancer has not been confirmed.
Pathologically Confirmed Cancer; Subject has pathologically confirmed lung cancer and is treatment naïve. Subject will be enrolled and provide a blood sample.	Other: Blood Sample Collection; Subjects participating in the study will have blood drawn at enrollment.; Other: Blood Sample Collection; Subjects participating in the study will have blood drawn at enrollment. Additional blood samples may be collected at 12 months from enrollment.; Other: Blood Sample Collection; Subjects participating in the study will have blood drawn at enrollment. Additional blood samples may be collected at 12 months from enrollment if lung cancer has not been confirmed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarker Identification	Screening subjects to find the appropriate methylation sites for the detection of lung cancer	Subjects could be followed for up to 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 11, 2016
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: August 9, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 16, 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

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules
• Other Study ID Numbers: 2016-01

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 requesors 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; Informed Consent Form (ICF); Clinical Study Report (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