2016-11: Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program

Sponsor

Exact Sciences Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT03628638

Collaborator

(none)

1,718

Enrollment

Locations

45.9

Actual Duration (Months)

55.4

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to establish a control population to assess performance of an investigational diagnostic test targeting lung neoplasms.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Blood Sample Collection

Detailed Description

Subjects will be participating in a lung cancer screening program at enrollment. Subjects will have a blood sample collected within 60 days of a low-dose CT scan (LDCT). Subjects with nodules present on the LDCT or subjects with a clean LDCT scheduled for a 12-month follow-up may have another blood draw at 12 months.

Study Design

Study Type:

Observational

Actual Enrollment :

1718 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

2016-11: Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program

Actual Study Start Date :

Apr 6, 2017

Actual Primary Completion Date :

Jan 31, 2021

Actual Study Completion Date :

Jan 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Lung Cancer Screening Patients - No Nodules Subjects in an low dose CT screening program that present no nodules.	Other: Blood Sample Collection Subjects participating in the study will have blood sample collected at enrollment. . For any subjects scheduled for a 12 month follow-up, additional blood samples will be collected at 12 months from enrollment.
Lung Cancer Screening Patients - Nodules Subjects in an low dose CT screening program that present nodules. Additional follow-up data will be collected for up to 12 months and an additional blood sample collected	Other: Blood Sample Collection Subjects participating in the study will have blood sample collected at enrollment. . For any subjects scheduled for a 12 month follow-up, additional blood samples will be collected at 12 months from enrollment.

Arm

Intervention/Treatment

Lung Cancer Screening Patients - No Nodules

Subjects in an low dose CT screening program that present no nodules.

Other: Blood Sample Collection

Subjects participating in the study will have blood sample collected at enrollment. . For any subjects scheduled for a 12 month follow-up, additional blood samples will be collected at 12 months from enrollment.

Lung Cancer Screening Patients - Nodules

Subjects in an low dose CT screening program that present nodules. Additional follow-up data will be collected for up to 12 months and an additional blood sample collected

Other: Blood Sample Collection

Outcome Measures

Primary Outcome Measures

Biomarker Identification [27 months]
Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood to detect lung cancer

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Subject is male or female, 50 years of age or older.
Subject meets one of two lung cancer screening criteria below.
Subject is a candidate for LDCT lung cancer screening and is scheduled for a baseline LDCT scan. There may be circumstances when a patient cannot have an LDCT scan (e.g., due to insurance issues). In these cases, it is allowable for a patient to have a CT scan in order to meet the inclusion criteria. OR
Subject has had previous LDCT scan(s) for lung cancer screening and the most recent LDCT scan prior to enrollment is negative for pulmonary nodules (Lung-RADS category 1, no nodules).
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.

Exclusion Criteria:

Subjects with pulmonary nodules on the most recent LDCT scan prior to enrollment (Lung-RADS category 1 nodules with specific calcifications such as complete, central, popcorn, concentric rings and fat containing nodules are excluded).
Prior history of cancer within the past 5 years except for non-melanoma skin cancer.
Prior removal of the lung, excluding percutaneous lung biopsy.
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.

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	Highlands Oncology Group	Springdale	Arkansas	United States	72762
4	NewportNativeMD, Inc.	Newport Beach	California	United States	92663
5	Palmtree Clinical Research, Inc.	Palm Springs	California	United States	92262
6	International Research Partners, LLC	Doral	Florida	United States	33122
7	Clinical Trials of Florida, LLC	Miami	Florida	United States	33186
8	Sarkis Clinical Trials	Ocala	Florida	United States	34474
9	Pasadena Center for Medical Research, Inc.	Saint Petersburg	Florida	United States	33707
10	Sarasota Memorial Hospital	Sarasota	Florida	United States	34239
11	UnityPoint Health - St. Luke's Hospital	Cedar Rapids	Iowa	United States	52402
12	Meritus Center for Clinical Research	Hagerstown	Maryland	United States	21742
13	Lahey Clinic, Inc.	Burlington	Massachusetts	United States	01805
14	Boone Hospital Center	Columbia	Missouri	United States	65201
15	Creighton University	Omaha	Nebraska	United States	68178
16	Pulmonary Ultimate Research Experience, LLC	Toms River	New Jersey	United States	08755
17	Northwell Health Physicians Pulmonary Medicine	Manhasset	New York	United States	11030
18	Gotham Cardiovascular Research, PC	New York	New York	United States	10001
19	Clinical Trials Developers, Inc.	Milford	Ohio	United States	45150
20	Chest Diseases of Northwestern PA	Erie	Pennsylvania	United States	16508
21	Allegheny Health Network	Pittsburgh	Pennsylvania	United States	15212
22	Research Protocol Management Specialists	Pittsburgh	Pennsylvania	United States	15243
23	Safe Harbor Clinical Research	East Providence	Rhode Island	United States	02914
24	Anderson Pharmaceutical Research, LLC	Anderson	South Carolina	United States	29621
25	Charleston Research Institution	Charleston	South Carolina	United States	29401
26	Medical University of South Carolina	Charleston	South Carolina	United States	29425
27	Clinical Research of Charleston	Mount Pleasant	South Carolina	United States	29494
28	South Carolina Pharmaceutical Research	Spartanburg	South Carolina	United States	29303
29	Union Pharmaceutical Research	Union	South Carolina	United States	29379
30	Pulmonary Associates of Richmond, Inc.	Richmond	Virginia	United States	23225
31	ProHealth Care	Waukesha	Wisconsin	United States	53188

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:

NCT03628638

Other Study ID Numbers:

2016-11

First Posted:

Aug 14, 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:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 15, 2021