Lung cancer can be deadly. It is the most common type of cancer to occur in the United States. Completing a screening test such as chest CT (computer tomography) scan can find early signs of lung cancer. When lung cancer is found early, treatment options may work better.

Joining this study may help researchers create another type of screening option for lung cancer. Researchers are working to create a lung cancer blood test that may be a more convenient and accessible way for people to screen for lung cancer. It is important to ensure that people of all backgrounds, ages, races, ethnicities and genders are represented in the group of research study participants to help create a new screening test for everyone, especially the high-risk smoking population.

Join us in the fight against lung cancer by spreading awareness on the importance of screening!

Freenome is working on an investigational (not yet approved for general use) blood test that may help find lung cancer. This test looks for something called DNA, which is a set of instructions inside your body. It tells your body how to grow and work properly. DNA is in every cell of your body. It is believed that when someone has lung cancer, there is more of this special DNA related to lung cancer in their blood.

To help us learn how to detect lung cancer earlier, we will collect samples of blood, health and lifestyle information, and the results of your lung cancer screening tests (chest CT scans, the test to check your lungs) from participants.

You will be on the study for up to 2 years.

As an interested study volunteer, you will:

1. First you will be asked to complete prescreening questions about  (medical history, lifestyle, and demographic information) (~10 minutes) to determine if you may qualify to join the study.

2. If you may qualify for the study based on the prescreening questions you answered, you will then be contacted via telephone by our study team to complete a few more screening questions (~15 minutes). You will also be asked to provide information about your upcoming lung cancer screening test (chest CT scan).

3. Next, if you are fully eligible to join the study and wish to continue forward, you will complete another phone call (~30 minutes) with our study team about one month prior to your scheduled lung cancer screening test (chest CT scan). During this call, you will review and sign the electronic informed consent form, complete additional study questions, and schedule the at-home blood draw (which must occur within 30 days of signing the informed consent).

4. Next, a mobile phlebotomist (a trained professional who can draw blood) from Portamedic will arrive at your home or location of your choice to complete the blood draw. They will collect up to 3 tablespoons of blood (~1 hour).

5. Within 45 days of completing the blood draw, you must complete your lung cancer screening test (chest CT scan) that has been scheduled for you by your local medical doctor.

6. Once your blood draw appointment and lung cancer screening test (chest CT scan) appointment have been completed, you will receive a $100 electronic gift card for your time and effort.

7. In 12 months, you will complete another standard of care lung cancer screening test (chest CT scan). Additionally, a member from our research study team will call you to gather updated health/lifestyle information.Upon confirmed completion you will receive a $75 electronic gift card for your time and effort.

8. In 24 months, you will complete another standard of care lung cancer screening test chest CT scan). Additionally, a member from our research study team will call you to gather updated health/lifestyle information. Upon confirmed completion you will receive $75 electronic gift card for your time and effort.

You will not directly benefit from taking part in this study.

The purpose of this study is to gather demographics, health history, lifestyle information, a blood specimen and lung cancer screening test (chest CT scan) results from study volunteers. The information collected will be used to help evaluate the blood test. The blood test could be used in the future to screen for lung cancer.

Finding lung cancer early when treatment may work best will save lives!

We understand that any medical choice requires time to think, process and fully understand the information available in order to make an informed decision.

It is possible you may still have questions about the study. If so, please call the Walgreens study team Monday through Friday, between 8am-8pm EST, toll free at 1-800-371-5450. A member of our team will be happy to answer your questions.

No. Insurance is not required to participate.

Please refer to the question ‘Do I have to pay to participate?’ for further details.

You will not have to pay for study-related events or procedures such as the collection of your medical history, lifestyle questions or the blood draw.

Your lung cancer screening tests (chest CT scans) will not be paid for by the study. You will need to work with your own doctor’s office and/or insurance provider to determine the cost of your chest CT scans.

IMPORTANT: Most insurance plans and Medicare help pay for recommended lung cancer screening CT chest scans. If the screening test finds something abnormal, you may need more tests. These follow-up tests may have a cost such as a co-pay or deductible. Check with your insurance plan to find out what benefits are covered for lung cancer screening. For more information about Medicare coverage, visit www.medicare.gov or call 1-800-MEDICARE (1-800-633-4227). TTY users should call 1 (877) 486-2048

A chest computerized tomography (CT) scan uses special medical equipment to take very detailed pictures of the organs in your chest. The pictures are taken and reviewed by a trained medical professional to make sure all of the organs appear normal and healthy. A chest CT scan can best be compared to an x-ray.⁵

During a chest CT scan, you will be asked to lay down on a table. While you are laying on the table a radiographer (trained medical professional) will control a medical camera that will move over and around your chest. The pictures that are captured will be of the organs in your chest. These pictures will be reviewed by a radiologist (a type of doctor who specializes in reading CT scan results) to determine if the organs in your chest appear normal and healthy.⁶

Please call your doctor’s office (likely your pulmonologist, an internal medicine or primary care doctor) to schedule your standard of care lung cancer screening test (chest CT scan).

The U.S. Preventive Services Task Force (USPSTF) is a group of people makes recommendations of healthcare. They recommend that a yearly lung cancer screening test (chest CT scan) should be completed by people who:

- Have a 20 pack-year or more smoking history, and

- Smoke now or have quit within the past 15 years, and

- Are between 50 and 80 years old.

A pack-year is smoking an average of one pack of cigarettes per day for one year. For example, a person could have a 20 pack-year history by smoking one pack a day for 20 years or two packs a day for 10 years².

No. This study will not impact your planned lung cancer screening test (chest CT scan). Please talk with your local medical team if you have questions about your lung cancer screening test (chest CT scan).

This research study is considered a prospective sample-collection study. This means that Walgreens and Freenome are working together to find volunteers, like yourself, who already plan to complete a lung cancer screening test (chest CT scan) as part of the standard of care recommended to you by your doctor. As a volunteer joining this study, you agree to donate your time, medical and lifestyle history, blood sample and screening lung cancer test (chest CT scan) results to help create a simple blood-based test. This test may be used in the future for early lung cancer screening.

This form is something that all study volunteers must sign before joining a research study. The form provides the information needed in order to make a choice about joining a research study.

The form outlines information about the study. It identifies study related activities and their risks/benefits. It also points out that study participation is voluntary and can be stopped at any time.

Yes. Joining a clinical research study is voluntary. You can decide to stop participating in the study at any time.

To stop participation in the study, you will need to contact the study team by telephone. Please call us Monday through Friday, between 8am-8pm EST, toll free at 1-800-371-5450 or email the study team at clinical-trials@walgreens.com. You will need to let the study team know that you no longer wish to be a part of the study. You do not need to give a reason why you want to stop participating.

It is possible that you may be asked to stop study participation. This would happen if the study team believes it is in your best interest, if you do not follow the study rules, or if the study is stopped.

Please contact a member of the research study team Monday through Friday, between 8am-8pm EST, toll free at 1-800-371-5450 and let them know you need help with the Walgreens & Freenome PROACT LUNG study.

Study participants will be paid three times for their time and effort:
- First, for the confirmed completion of the Enrollment visit, which includes the at-home blood draw and baseline lung cancer screening test (chest CT scan) ($100)

- Second, for confirmed completion of the follow-up 12-month lung cancer screening test (chest CT scan) and updated health/lifestyle information ($75)

- Third, for confirmed completion of the follow-up 24-month lung cancer screening test (chest CT scan) and updated health/lifestyle information ($75)

Payments will be sent via email in the form of an electronic Visa® reward card to the email you provide in the participant portal.

If you are not comfortable with a mobile phlebotomist from Portamedic coming to your home for the required blood draw, you and a member of the Portamedic team can agree on another location to complete the blood draw.

For example, you may feel more comfortable at a family member’s/friend’s home or a local Walgreens location.

The purpose of the at-home blood draw service is to help meet study participants where they are, and to reduce the time spent on study participation. We greatly value your interest in the study, and we want to make sure you feel comfortable if you decide to join the study.

Yes. You will receive another electronic gift card payment of $75 for your time and effort if your blood draw needs to be repeated.

Yes! All study information is available in Spanish.

Walgreens and Freenome value your interest in the study. It is important to us that you have what you need to understand the study and to make an informed decision. Community representation in clinical research is key in improving medicine for all.

Spreading awareness and education about lung cancer and the importance of screening is necessary for people that have a smoking history can be lifesaving. Early detection of lung cancer saves lives.

Please share the link below if you know someone that should get screened!

https://mywalgreenstrials.com/ruKVlr

Please visit the following link to learn more:

https://www.freenome.com