Clinical trial NCT03633006: Blood Sample Collection in Subjects With Pulmonary Nodules or CT Suspicion of Lung Cancer or Pathologically Diagnosed Lung Cancer
Official title: Blood Sample Collection in Subjects With Pulmonary Nodules or CT Suspicion of Lung Cancer or Pathologically Diagnosed Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer (Diagnosis)
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
First posted: 2018-08-16
Enrollment: 3298
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Biomarker Identification
timeFrame: Subjects could be followed for up to 27 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research
state: Alabama
city: Peoria
country: United States
facility: Phoenix Medical Group
state: Arizona
city: Newport Beach
country: United States
facility: Newport NativeMD
state: California
city: Palm Springs
country: United States
facility: Palmtree Clinical Research, Inc
state: California
city: Palo Alto
country: United States
facility: Palo Alto Veterans Health Care
state: California
city: Upland
country: United States
facility: Premier Medical Group
state: California
city: Cutler Bay
country: United States
facility: American Research Institute, Inc
state: Florida
city: Doral
country: United States
facility: International Research Partners, LLC
state: Florida
city: Jupiter
country: United States
facility: Jupiter Medical Center
state: Florida
city: Kissimmee
country: United States
facility: Pulmonary Disease Specialists
state: Florida
city: Leesburg
country: United States
facility: Medical Research of Central Florida, LLC
state: Florida
city: Miami Gardens
country: United States
facility: AMPM research Clinic
state: Florida
city: Miami
country: United States
facility: Future Clinical Research
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Miami
country: United States
facility: Orcinova AMS Research
state: Florida
city: Miami
country: United States
facility: Sunrise Research Institute, Inc
state: Florida
city: Miami
country: United States
facility: American Research Medical Group
state: Florida
city: Miami
country: United States
facility: Health and Life Research Institute, LLC
state: Florida
city: Miami
country: United States
facility: Care Research Center
state: Florida
city: Miami
country: United States
facility: Clinical Trials of Florida, LLC
state: Florida
city: Saint Petersburg
country: United States
facility: Coastal Pulmonary and Critical Care, PLC
state: Florida
city: Saint Petersburg
country: United States
facility: Pasadena Center for Medical Research, Inc
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital Clinical Research Center
state: Florida
city: Winter Park
country: United States
facility: Florida Pulmonary Research Institute, LLC
state: Florida
city: Winter Park
country: United States
facility: Pulmonary Care Research Group, PA
state: Florida
city: Atlanta
country: United States
facility: Piedmont Healthcare, Inc.
state: Georgia
city: Buford
country: United States
facility: Gwinnett Research institute, LLC
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Lawrenceville
country: United States
facility: Gwinnett Biomedical Research
state: Georgia
city: Marietta
country: United States
facility: DC Research Work
state: Georgia
city: Rincon
country: United States
facility: Southeast Lung Associates Research
state: Georgia
city: Nampa
country: United States
facility: Saltzer Medical Group
state: Idaho
city: Champaign
country: United States
facility: PMG Research of Christie Clinic
state: Illinois
city: Chicago
country: United States
facility: Medical and Procedural Specialists of Illinois, LLC
state: Illinois
city: Maywood
country: United States
facility: Loyola University Chicago
state: Illinois
city: Anderson
country: United States
facility: Community Hospital of Anderson and Madison County, Inc.
state: Indiana
city: Augusta
country: United States
facility: Heartland Research Associates, LLC-An AMR Company
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Hagerstown
country: United States
facility: Meritus Center for Clinical Research
state: Maryland
city: Hollywood
country: United States
facility: MedStar Shah Medical Group
state: Maryland
city: Burlington
country: United States
facility: Lahey Clinic, Inc
state: Massachusetts
city: Newton
country: United States
facility: Newton-Wellesley Hospital
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Lincoln
country: United States
facility: Somnos Laboratories
state: Nebraska
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: Marlton
country: United States
facility: Virtua Health, Inc
state: New Jersey
city: Toms River
country: United States
facility: Pulmonary Ultimate Research Experience, LLC (PURE, LLC)
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College MC-91
state: New York
city: Jamaica
country: United States
facility: Jamaica Hospital Medical Center
state: New York
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
city: Charlotte
country: United States
facility: American Health Research, LLC
state: North Carolina
city: Gastonia
country: United States
facility: Clinical Research of Gastonia
state: North Carolina
city: Gastonia
country: United States
facility: Gastonia Pharmaceutical Research
state: North Carolina
city: Greensboro
country: United States
facility: Pulmonix, LLC
state: North Carolina
city: Hickory
country: United States
facility: Hickory Research Center DBA Research Carolina of Hickory
state: North Carolina
city: New Bern
country: United States
facility: Coastal Carolina Health Care
state: North Carolina
city: Rocky Mount
country: United States
facility: PMG Research of Rocky Mount, LLC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Milford
country: United States
facility: Clinical Trial Developers, Inc.
state: Ohio
city: Edmond
country: United States
facility: OK Clinical Research, LLC
state: Oklahoma
city: Portland
country: United States
facility: The Oregon Clinic, PC
state: Oregon
city: Erie
country: United States
facility: Chest Diseases of Northwestern PA
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Protocol Management Specialists
state: Pennsylvania
city: East Providence
country: United States
facility: Safe Harbor Clinical Research
state: Rhode Island
city: Anderson
country: United States
facility: Anderson Pharmaceutical Research, LLC
state: South Carolina
city: Charleston
country: United States
facility: Charletson Research Institute
state: South Carolina
city: Charleston
country: United States
facility: The Medical University of South Carolina
state: South Carolina
city: Gaffney
country: United States
facility: VitaLink Research--Gaffney (Gaffney Pharmaceutical Research, LLC)
state: South Carolina
city: Mount Pleasant
country: United States
facility: Clinical Research of Charleston
state: South Carolina
city: Rock Hill
country: United States
facility: Clinical Research of Rock HIll
state: South Carolina
city: Rock Hill
country: United States
facility: VitaLink Research-Rock Hill
state: South Carolina
city: Spartanburg
country: United States
facility: South Carolina Pharmaceutical Research, LLC
state: South Carolina
city: Union
country: United States
facility: Union Pharmaceutical Research
state: South Carolina
city: Cypress
country: United States
facility: Houston Pulmonary Sleep and Allergy Associates
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Laredo
country: United States
facility: Envision Cancer Care, LLC
state: Texas
city: The Woodlands
country: United States
facility: Renovatio Clinical Consultants, LLC
state: Texas
city: The Woodlands
country: United States
facility: Renovatio Clinical
state: Texas
city: Richmond
country: United States
facility: Pulmonary Associates of Richmond
state: Virginia
city: Bellevue
country: United States
facility: Overlake Hospital Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
city: Madison
country: United States
facility: William S. Middleton Memorial Veterans Hospital
state: Wisconsin
Study officials:
affiliation: Exact Sciences
name: Laura Strong
role: STUDY_DIRECTOR
References: