Healthy2016-11NCT03628638
Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program
An observational study of Healthy, run by Exact Sciences Corporation at 31 sites in United States.
Trial summary
The primary objective of this study is to establish a control population to assess performance of an investigational diagnostic test targeting lung neoplasms. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Blood Sample Collection
- How many people
- 1,718 participants
- Where
- 31 sitesUnited States
- Study dates
- 6 Apr 2017to 31 Jan 2021
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be men and women, 50 years of age or older. Subjects will be participating in a lung cancer screening program at the time of enrollment.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Anderson Pharmaceutical Research, LLC
Anderson, South Carolina, 29621
Achieve Clinical Research
Birmingham, Alabama, 35216
Lahey Clinic, Inc.
Burlington, Massachusetts, 01805
UnityPoint Health - St. Luke's Hospital
Cedar Rapids, Iowa, 52402
Charleston Research Institution
Charleston, South Carolina, 29401
Medical University of South Carolina
Charleston, South Carolina, 29425
Boone Hospital Center
Columbia, Missouri, 65201
International Research Partners, LLC
Doral, Florida, 33122
Safe Harbor Clinical Research
East Providence, Rhode Island, 02914
Chest Diseases of Northwestern PA
Erie, Pennsylvania, 16508
Meritus Center for Clinical Research
Hagerstown, Maryland, 21742
Northwell Health Physicians Pulmonary Medicine
Manhasset, New York, 11030
Clinical Trials of Florida, LLC
Miami, Florida, 33186
Clinical Trials Developers, Inc.
Milford, Ohio, 45150
Clinical Research of Charleston
Mt. Pleasant, South Carolina, 29494
Gotham Cardiovascular Research, PC
New York, New York, 10001
NewportNativeMD, Inc.
Newport Beach, California, 92663
Sarkis Clinical Trials
Ocala, Florida, 34474
Creighton University
Omaha, Nebraska, 68178
Palmtree Clinical Research, Inc.
Palm Springs, California, 92262
Phoenix Medical Group
Peoria, Arizona, 85381
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Research Protocol Management Specialists
Pittsburgh, Pennsylvania, 15243
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, 23225
Sarasota Memorial Hospital
Sarasota, Florida, 34239
South Carolina Pharmaceutical Research
Spartanburg, South Carolina, 29303
Highlands Oncology Group
Springdale, Arkansas, 72762
Pasadena Center for Medical Research, Inc.
St. Petersburg, Florida, 33707
Pulmonary Ultimate Research Experience, LLC
Toms River, New Jersey, 08755
Union Pharmaceutical Research
Union, South Carolina, 29379
ProHealth Care
Waukesha, Wisconsin, 53188
About this study
Official title: 2016-11: Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program
The primary objective of this study is to establish a control population to assess performance of an investigational diagnostic test targeting lung neoplasms.
Read the 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.
- Conditions
- Healthy
- Being tested
- Blood Sample Collection
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 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.
| Study group | Role | What they receive |
|---|---|---|
| Lung Cancer Screening Patients - No Nodules | Subjects in an low dose CT screening program that present no nodules. Receives: Other: Blood Sample Collection | |
| 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 Receives: Other: Blood Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker Identification
Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood to detect lung cancer
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start6 Apr 2017
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,718 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exact Sciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura Strong, Study director, Exact Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628638
- Sponsor's protocol ID
- 2016-11
- Acronym
- 2016-11
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2016-11: Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program
- ClinicalTrials.gov ID
- NCT03628638
- Acronym / sponsor ID
- 2016-11 / 2016-11
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,718 participants (actual)
- Lead sponsor
- Exact Sciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to establish a control population to assess performance of an investigational diagnostic test targeting lung neoplasms.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung Cancer Screening Patients - No Nodules | – | Other: Blood Sample CollectionSubjects in an low dose CT screening program that present no nodules. |
| Lung Cancer Screening Patients - Nodules | – | Other: Blood Sample CollectionSubjects 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be men and women, 50 years of age or older. Subjects will be participating in a lung cancer screening program at the time of enrollment.
Key inclusion criteria (5 listed)
- Subject is male or female, 50 years of age or older.
- Subject meets one of two lung cancer screening criteria below.
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Sample CollectionSubjects 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. | Other | Lung Cancer Screening Patients - No Nodules, Lung Cancer Screening Patients - Nodules |
Primary outcome
Biomarker Identification
Time frame: 27 months
Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood to detect lung cancer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Strong study director
Exact Sciences
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Exact Sciences Corporation at 31 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 5 inclusion and 4 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 31 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: 27 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.