Clincosm LogoSign in Get a demo

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

Sponsor
Exact Sciences Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT03633006
Collaborator
(none)
3,298
Enrollment
83
Locations
56.7
Actual Duration (Months)
39.7
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
3298 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Blood Sample Collection in Subjects With Pulmonary Nodules or CT Suspicion of Lung Cancer or Pathologically Diagnosed Lung Cancer
Actual Study Start Date :
Apr 11, 2016
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm 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. Additional blood samples may be collected at 12 months from enrollment.
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. 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.

Outcome Measures

Primary Outcome Measures

  1. Biomarker Identification [Subjects could be followed for up to 27 months.]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:
  1. Subject has CT suspicion of lung cancer and is scheduled for biopsy or other diagnostic procedure.
Pathologically Confirmed Cancer Subjects:
  1. Subject has pathologically confirmed lung cancer and is treatment naïve.
Pulmonary Nodule Subjects:
  1. 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:

  1. Biopsy within 7 days prior to blood collection.

  2. Unresolved bleeding as a result of biopsy at the time of enrollment.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Achieve Clinical Research Birmingham Alabama United States 35216
2 Phoenix Medical Group Peoria Arizona United States 85381
3 Newport NativeMD Newport Beach California United States 92663
4 Palmtree Clinical Research, Inc Palm Springs California United States 92262
5 Palo Alto Veterans Health Care Palo Alto California United States 94304
6 Premier Medical Group Upland California United States 91786
7 American Research Institute, Inc Cutler Bay Florida United States 33157
8 International Research Partners, LLC Doral Florida United States 33122
9 Jupiter Medical Center Jupiter Florida United States 33458
10 Pulmonary Disease Specialists Kissimmee Florida United States 34741
11 Medical Research of Central Florida, LLC Leesburg Florida United States 34748
12 AMPM research Clinic Miami Gardens Florida United States 33169
13 Future Clinical Research Miami Florida United States 33122
14 University of Miami Miller School of Medicine Miami Florida United States 33125
15 Orcinova AMS Research Miami Florida United States 33130
16 Sunrise Research Institute, Inc Miami Florida United States 33130
17 American Research Medical Group Miami Florida United States 33144
18 Health and Life Research Institute, LLC Miami Florida United States 33155
19 Care Research Center Miami Florida United States 33175
20 Clinical Trials of Florida, LLC Miami Florida United States 33186
21 Coastal Pulmonary and Critical Care, PLC Saint Petersburg Florida United States 33704
22 Pasadena Center for Medical Research, Inc Saint Petersburg Florida United States 33707
23 Sarasota Memorial Hospital Clinical Research Center Sarasota Florida United States 34239
24 Florida Pulmonary Research Institute, LLC Winter Park Florida United States 32789
25 Pulmonary Care Research Group, PA Winter Park Florida United States 32789
26 Piedmont Healthcare, Inc. Atlanta Georgia United States 30309
27 Gwinnett Research institute, LLC Buford Georgia United States 30519
28 Columbus Regional Research Institute Columbus Georgia United States 60631
29 Gwinnett Biomedical Research Lawrenceville Georgia United States 30046
30 DC Research Work Marietta Georgia United States 30060
31 Southeast Lung Associates Research Rincon Georgia United States 31326
32 Saltzer Medical Group Nampa Idaho United States 83686
33 PMG Research of Christie Clinic Champaign Illinois United States 61820
34 Medical and Procedural Specialists of Illinois, LLC Chicago Illinois United States 60631
35 Loyola University Chicago Maywood Illinois United States 60153
36 Community Hospital of Anderson and Madison County, Inc. Anderson Indiana United States 46011
37 Heartland Research Associates, LLC-An AMR Company Augusta Kansas United States 67010
38 Johns Hopkins University School of Medicine Baltimore Maryland United States 21287
39 Meritus Center for Clinical Research Hagerstown Maryland United States 21742
40 MedStar Shah Medical Group Hollywood Maryland United States 20636
41 Lahey Clinic, Inc Burlington Massachusetts United States 01805
42 Newton-Wellesley Hospital Newton Massachusetts United States 02462
43 Baystate Medical Center Springfield Massachusetts United States 01199
44 Somnos Laboratories Lincoln Nebraska United States 68510
45 Creighton University Omaha Nebraska United States 68178
46 Virtua Health, Inc Marlton New Jersey United States 08053
47 Pulmonary Ultimate Research Experience, LLC (PURE, LLC) Toms River New Jersey United States 08755
48 Albany Medical College MC-91 Albany New York United States 12208
49 Jamaica Hospital Medical Center Jamaica New York United States 11418
50 Northwell Health New Hyde Park New York United States 11040
51 American Health Research, LLC Charlotte North Carolina United States 28277
52 Clinical Research of Gastonia Gastonia North Carolina United States 28054
53 Gastonia Pharmaceutical Research Gastonia North Carolina United States 28054
54 Pulmonix, LLC Greensboro North Carolina United States 27403
55 Hickory Research Center DBA Research Carolina of Hickory Hickory North Carolina United States 28601
56 Coastal Carolina Health Care New Bern North Carolina United States 28562
57 PMG Research of Rocky Mount, LLC Rocky Mount North Carolina United States 27804
58 PMG Research of Wilmington, LLC Wilmington North Carolina United States 28401
59 Cleveland Clinic Cleveland Ohio United States 44195
60 Clinical Trial Developers, Inc. Milford Ohio United States 45150
61 OK Clinical Research, LLC Edmond Oklahoma United States 73034
62 The Oregon Clinic, PC Portland Oregon United States 97220
63 Chest Diseases of Northwestern PA Erie Pennsylvania United States 16508
64 Research Protocol Management Specialists Pittsburgh Pennsylvania United States
65 Safe Harbor Clinical Research East Providence Rhode Island United States 02914
66 Anderson Pharmaceutical Research, LLC Anderson South Carolina United States 29621
67 Charletson Research Institute Charleston South Carolina United States 29401
68 The Medical University of South Carolina Charleston South Carolina United States 29425
69 VitaLink Research--Gaffney (Gaffney Pharmaceutical Research, LLC) Gaffney South Carolina United States 29340
70 Clinical Research of Charleston Mount Pleasant South Carolina United States 29464
71 Clinical Research of Rock HIll Rock Hill South Carolina United States 29732
72 VitaLink Research-Rock Hill Rock Hill South Carolina United States 29732
73 South Carolina Pharmaceutical Research, LLC Spartanburg South Carolina United States 29303
74 Union Pharmaceutical Research Union South Carolina United States 29379
75 Houston Pulmonary Sleep and Allergy Associates Cypress Texas United States 77429
76 University of Texas Medical Branch Galveston Texas United States 77555
77 Envision Cancer Care, LLC Laredo Texas United States 78041
78 Renovatio Clinical Consultants, LLC The Woodlands Texas United States 77380
79 Renovatio Clinical The Woodlands Texas United States 77380
80 Pulmonary Associates of Richmond Richmond Virginia United States 23225
81 Overlake Hospital Medical Center Bellevue Washington United States 98004
82 University of Wisconsin School of Medicine and Public Health Madison Wisconsin United States 53705
83 William S. Middleton Memorial Veterans Hospital Madison Wisconsin United States 53705

Sponsors and Collaborators

  • Exact Sciences Corporation

Investigators

  • Study Director: Laura Strong, Exact Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Exact Sciences Corporation
ClinicalTrials.gov Identifier:
NCT03633006
Other Study ID Numbers:
  • 2016-01
First Posted:
Aug 16, 2018
Last Update Posted:
Feb 15, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lung Neoplasms
Multiple Pulmonary Nodules
Neoplasms

Study Results

No Results Posted as of Feb 15, 2021