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

Lung Cancer (Diagnosis) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03633006
• Other study ID #: 2016-01
• Status: Completed
• Start date: April 11, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: Exact Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3298
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer (Diagnosis)
• Lung Neoplasms
• Multiple Pulmonary Nodules
• Neoplasms

Intervention

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.
• 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.
• Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Exact Sciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.