FAQs
The purpose of the SENTINEL study is to evaluate a new cancer screening test and how those results might be helpful in a military population.
This new test is called Galleri® and is designed to detect over 50 types of cancer using a single blood draw.
This is an investigational test, which means that the Galleri® test is not yet approved by the U. S. Food and Drug Administration (FDA.)
However, many healthcare providers are already recommending it to patients, and it is already commercially available.
The Department of Defense (DoD) is funding this study and has chosen Dana-Farber Cancer Institute to lead the medical research portion of the project.
Who is eligible?
You may be eligible to participate in the SENTINEL study if you have:
Active-duty or National Guard/Reserves military service for 8+ years,
Age of least 45 years old
Received care at a VA facility within past 5 years,
Are able to sign informed consent
Willingness to travel to Dana-Farber Cancer Institute in Boston, MA, for diagnostic testing if screening test indicates possible malignancy.
Not already received a multi-cancer screening in the last 12 months
Who is not eligible?
You may not be eligible to participate if you have:
Served less than 8 years in either active-duty or National Guard / Reserves
Have a recent cancer diagnosis –
People who have been diagnosed with or received treatment for an invasive or hematologic cancer in the past three years are not eligible.
(Note: Hormone therapy for breast/prostate cancer is allowed).
It is also okay if you have had cancer in the past, as long as it was diagnosed and treated more than 3 years ago.
No. Taking part in this study is voluntary. Even if you decide to participate, you can change your mind and leave the study at any time.
For you: You may or may not directly benefit from participating in this study. It is
anticipated that some participants will have a cancer “signal detected” test result and
subsequent work-up could lead to a diagnosis of cancer, which could then be
treated.
This may result in an earlier diagnosis than if you did not participate in
the study. Additionally, some people may appreciate the screening yielding a negative result, knowing they are being proactive about their health outcomes and dealing with any indicators.
For others: Your participation will help researchers determine whether multi-cancer blood tests
can detect cancers at an early stage and how the results may help others in the future.
There will be no additional costs to you for participating in this study.
However, we will do various medical tests as part of this study. We will give you the results. When you receive potential follow-up care if screened positive, your doctor will bill you or your insurance company per usual practice. If you do not have insurance, or if your insurance will not pay, you will be responsible for the cost of follow-up care.
Initial Participation Agreement - about 20 minutes each.
Participation includes signing an informed consent document
Completing both baseline and post-testing questionnaires
Lab Test - about 15 minutes
You will also have a blood draw for the Galleri test
Participants who test positive will also have additional diagnostic testing.
If you have questions about timing or scheduling, please contact us.
Some people may experience one or more physical or emotional consequences as a result of participating in this research study. They could include:
Feelings of anticipation and anxiousness about the possible results of the screening
A potential “false positive” test result that can result in unnecessary diagnostic work-up not leading to an eventual cancer diagnosis.
Potential bruising or temporary discomfort associated with a blood draw
Personal questions about your medical and military history may cause emotional responses if the answers are uncomfortable for you.
In the unlikely event of a positive cancer signal, the participant may experience some emotional or physical effects related to follow-up procedures, scans or other procedures
that your doctor recommends.
Although these are realities of participating in any research study, many people experience the end results as beneficial, whether to them or to the broader population of veterans. We encourage you to take some time to think this over, to discuss it with other
people and your primary doctor, and to ask questions at any time to determine if participation is right for you.
We will take measures to protect the privacy and security of all your personal information, but we cannot guarantee complete confidentiality of study data. Information about you and your health is personal and private. Generally, it
cannot be obtained without your written permission.
By signing this consent form, you are providing that permission and your information may be obtained and used in accordance with the purposes of the study and the uses listed in this informed consent and as required or allowed by law.
What the consent document allows, specifically: This consent means that researchers may obtain information regarding your test results, your past medical history, as well as specimens and samples from previous health care providers such as hospitals and labs.
