AzTrials
AzTrials

Lung Cancer (Diagnosis)NCT03633006

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

An observational study of Lung Cancer (Diagnosis), run by Exact Sciences Corporation at 83 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
Lung Cancer (Diagnosis)
What is being tested?
Blood Sample Collection
How many people
3,298 participants
Where
83 sitesUnited States
Study dates
11 Apr 2016to 31 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • All Subjects:
  • Subject is male or female, 35 years of age or older.
  • Subject has at least one CT confirmed 6-30 mm nodule.
  • 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:
  • Subject has CT suspicion of lung cancer and is scheduled for biopsy or other diagnostic procedure.
Show all 10Show fewer
  • 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).

Who cannot join

  • All Subjects
  • CT with IV contrast within 1 day [or 24 hours] of blood collection.
  • 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.
  • Prior removal of the lung, excluding percutaneous lung biopsy.
  • Treatment (e.g., surgical resection, radiofrequency ablation) for pulmonary nodules prior to blood sample collection for this trial.
  • 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.
Show all 9Show fewer
  • Pathologically Confirmed Cancer Subjects:
  • Biopsy within 7 days prior to blood collection.
  • Unresolved bleeding as a result of biopsy at the time of enrollment.

Trial locations and contacts

83 sites in 1 country.

83 sites in 1 country

United States83 sites

  • Albany Medical College MC-91

    Albany, New York, 12208

  • Community Hospital of Anderson and Madison County, Inc.

    Anderson, Indiana, 46011

  • Anderson Pharmaceutical Research, LLC

    Anderson, South Carolina, 29621

  • Piedmont Healthcare, Inc.

    Atlanta, Georgia, 30309

  • Heartland Research Associates, LLC-An AMR Company

    Augusta, Kansas, 67010

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21287

  • Overlake Hospital Medical Center

    Bellevue, Washington, 98004

  • Achieve Clinical Research

    Birmingham, Alabama, 35216

  • Gwinnett Research institute, LLC

    Buford, Georgia, 30519

  • Lahey Clinic, Inc

    Burlington, Massachusetts, 01805

  • PMG Research of Christie Clinic

    Champaign, Illinois, 61820

  • Charletson Research Institute

    Charleston, South Carolina, 29401

  • The Medical University of South Carolina

    Charleston, South Carolina, 29425

  • American Health Research, LLC

    Charlotte, North Carolina, 28277

  • Medical and Procedural Specialists of Illinois, LLC

    Chicago, Illinois, 60631

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Columbus Regional Research Institute

    Columbus, Georgia, 60631

  • American Research Institute, Inc

    Cutler Bay, Florida, 33157

  • Houston Pulmonary Sleep and Allergy Associates

    Cypress, Texas, 77429

  • International Research Partners, LLC

    Doral, Florida, 33122

  • Safe Harbor Clinical Research

    East Providence, Rhode Island, 02914

  • OK Clinical Research, LLC

    Edmond, Oklahoma, 73034

  • Chest Diseases of Northwestern PA

    Erie, Pennsylvania, 16508

  • VitaLink Research--Gaffney (Gaffney Pharmaceutical Research, LLC)

    Gaffney, South Carolina, 29340

  • University of Texas Medical Branch

    Galveston, Texas, 77555

  • Clinical Research of Gastonia

    Gastonia, North Carolina, 28054

  • Gastonia Pharmaceutical Research

    Gastonia, North Carolina, 28054

  • Pulmonix, LLC

    Greensboro, North Carolina, 27403

  • Meritus Center for Clinical Research

    Hagerstown, Maryland, 21742

  • Hickory Research Center DBA Research Carolina of Hickory

    Hickory, North Carolina, 28601

  • MedStar Shah Medical Group

    Hollywood, Maryland, 20636

  • Jamaica Hospital Medical Center

    Jamaica, New York, 11418

  • Jupiter Medical Center

    Jupiter, Florida, 33458

  • Pulmonary Disease Specialists

    Kissimmee, Florida, 34741

  • Envision Cancer Care, LLC

    Laredo, Texas, 78041

  • Gwinnett Biomedical Research

    Lawrenceville, Georgia, 30046

  • Medical Research of Central Florida, LLC

    Leesburg, Florida, 34748

  • Somnos Laboratories

    Lincoln, Nebraska, 68510

  • University of Wisconsin School of Medicine and Public Health

    Madison, Wisconsin, 53705

  • William S. Middleton Memorial Veterans Hospital

    Madison, Wisconsin, 53705

  • DC Research Work

    Marietta, Georgia, 30060

  • Virtua Health, Inc

    Marlton, New Jersey, 08053

  • Loyola University Chicago

    Maywood, Illinois, 60153

  • Future Clinical Research

    Miami, Florida, 33122

  • University of Miami Miller School of Medicine

    Miami, Florida, 33125

  • Orcinova AMS Research

    Miami, Florida, 33130

  • Sunrise Research Institute, Inc

    Miami, Florida, 33130

  • American Research Medical Group

    Miami, Florida, 33144

  • Health and Life Research Institute, LLC

    Miami, Florida, 33155

  • Care Research Center

    Miami, Florida, 33175

  • Clinical Trials of Florida, LLC

    Miami, Florida, 33186

  • AMPM research Clinic

    Miami Gardens, Florida, 33169

  • Clinical Trial Developers, Inc.

    Milford, Ohio, 45150

  • Clinical Research of Charleston

    Mt. Pleasant, South Carolina, 29464

  • Saltzer Medical Group

    Nampa, Idaho, 83686

  • Coastal Carolina Health Care

    New Bern, North Carolina, 28562

  • Northwell Health

    New Hyde Park, New York, 11040

  • Newport NativeMD

    Newport Beach, California, 92663

  • Newton-Wellesley Hospital

    Newton, Massachusetts, 02462

  • Creighton University

    Omaha, Nebraska, 68178

  • Palmtree Clinical Research, Inc

    Palm Springs, California, 92262

  • Palo Alto Veterans Health Care

    Palo Alto, California, 94304

  • Phoenix Medical Group

    Peoria, Arizona, 85381

  • Research Protocol Management Specialists

    Pittsburgh, Pennsylvania

  • The Oregon Clinic, PC

    Portland, Oregon, 97220

  • Pulmonary Associates of Richmond

    Richmond, Virginia, 23225

  • Southeast Lung Associates Research

    Rincon, Georgia, 31326

  • Clinical Research of Rock HIll

    Rock Hill, South Carolina, 29732

  • VitaLink Research-Rock Hill

    Rock Hill, South Carolina, 29732

  • PMG Research of Rocky Mount, LLC

    Rocky Mount, North Carolina, 27804

  • Sarasota Memorial Hospital Clinical Research Center

    Sarasota, Florida, 34239

  • South Carolina Pharmaceutical Research, LLC

    Spartanburg, South Carolina, 29303

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Coastal Pulmonary and Critical Care, PLC

    St. Petersburg, Florida, 33704

  • Pasadena Center for Medical Research, Inc

    St. Petersburg, Florida, 33707

  • Renovatio Clinical Consultants, LLC

    The Woodlands, Texas, 77380

  • Renovatio Clinical

    The Woodlands, Texas, 77380

  • Pulmonary Ultimate Research Experience, LLC (PURE, LLC)

    Toms River, New Jersey, 08755

  • Union Pharmaceutical Research

    Union, South Carolina, 29379

  • Premier Medical Group

    Upland, California, 91786

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

  • Florida Pulmonary Research Institute, LLC

    Winter Park, Florida, 32789

  • Pulmonary Care Research Group, PA

    Winter Park, Florida, 32789

Other trials in United States

About this study

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.

Read the 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.

Being tested
Blood Sample Collection
Medical subject headings
Lung Neoplasms, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood Sample CollectionOther

    Subjects participating in the study will have blood drawn at enrollment. Additional blood samples may be collected at 12 months from enrollment.

  • Blood Sample CollectionOther

    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.

  • Blood Sample CollectionOther

    Subjects participating in the study will have blood drawn at enrollment.

Study groups in NCT03633006
Study groupRoleWhat they receive
Pulmonary NodulesSubject 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.
Receives: Other: Blood Sample Collection
CT Suspicion of CancerSubject with suspicion of lung cancer will provide a blood sample. Diagnostic information will be collected to confirm the final diagnosis.
Receives: Other: Blood Sample Collection
Pathologically Confirmed CancerSubject has pathologically confirmed lung cancer and is treatment naïve. Subject will be enrolled and provide a blood sample.
Receives: Other: Blood Sample Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biomarker Identification

    Screening subjects to find the appropriate methylation sites for the detection of lung cancer

    Measured: Subjects could be followed for up to 27 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2018
  2. Study start11 Apr 2016
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,298 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03633006
Sponsor's protocol ID
2016-01
Status last verified
Feb 2021
First submitted
9 Aug 2018
Last updated
15 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer (Diagnosis), run by Exact Sciences Corporation at 83 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biomarker Identification (time frame: Subjects could be followed for up to 27 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03633006.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in