Early detection saves lives

Are you 40 years of age or older, with no history of cancer (with the exception of skin cancer) and planning to have a colonoscopy? You may be eligible to join the PROCEED-CRC study to help develop a blood test to detect colorectal cancer earlier. Study volunteers will be compensated for their time and effort.

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Why is The Synchronize Study important?

“Overweight” and “obesity” are complex, chronic health conditions that can be caused by several factors, such as genetics (passed on from one generation to the next), environment, hormones, or other medical conditions. While nutrition and physical activity has been proven to help many in managing their weight, for some, more help may be needed. The SYNCHRONIZE studies will help doctors understand if a new treatment to help with weight loss is safe and effective among different groups of people.

Why is this study important?

Colorectal Cancer (CRC) is the third most common cancer and the 2nd deadliest cancer in the United States.1,2 Males, Black, American Indian and Alaska Natives are at highest risk for CRC. Screening, starting at age 45, can save lives.3

1 in 24 people will be diagnosed with CRC in their lifetime.3

What is this study about?

The blood draw and health information collected from each study participant may help develop a blood test used to screen for colorectal cancer (CRC). The convenience of a blood test may increase the number of people completing routine CRC screenings, improve CRC early detection and prevention, and reduce death rates.    

CRC is cancer found in the colon or rectum - parts of the digestive tract. CRC is more easily- treated and even preventable if found early through screening tests like a colonoscopy.3 The American Cancer Society recommends adults with no family history to begin CRC screening at age 45.3

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Who is able to participate?

Those who meet the following criteria may be eligible:

Age 40 or older

No history of cancer (exception skin cancer)

Willing to have a blood draw

Scheduled/planning a colonoscopy within the next 4 months

Have not completed a colonoscopy in the last 9 years

Willing to sign informed consent

This study will not interfere with your planned colonoscopy.

What do I have to do to participate?

  • Take a short online survey (~10 minutes) to see if you pre-qualify for the study.
  • If you pre-qualify, you will review/sign an online informed consent and complete the enrollment questions (~30 minutes).
  • Then, you will schedule an at-home blood draw to be completed before your colonoscopy.
  • A mobile phlebotomist (a trained professional that can draw blood) from Portamedic will arrive at your home or location of your choice and complete the blood draw (~1hour). Once the blood draw is complete, you will receive a $75 electronic card for your time and effort.
  • Next, you will attend your scheduled colonoscopy ordered by your own doctor. This study does not interfere with your planned colonoscopy.
  • Finally, once your colonoscopy has been completed, you will confirm the date of completion online and will receive a $75 electronic card for your time and effort for the study.
Thank you! Your submission has been received!
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Refer friends and family into the study!

Early screening for colorectal cancer (CRC) may save a life! Encourage your friends and family members to complete on-time, routine screenings.

If someone you know is scheduled or due to have a colonoscopy soon, share the study link below and help spread awareness about this study opportunity and the importance of colorectal cancer screening.

https://crcstudy.info/friend

Frequently asked questions

Why should I participate in this study?
Colorectal cancer (CRC)or better known as Colon cancer can be deadly. It is the third most common typeof cancer to occur in the United States. 1 Completing a screening test like a colonoscopy can find early signs of CRC and save a life. 2,3 

Joining this study may help researchers create another CRC screening option that people may use in the future to find CRC. Researchers are working to create a CRC screening blood test that may be more comfortable, and more convenient for people compared to a colonoscopy.  

To help create a new test for everyone, it is important that people of all backgrounds, ages, races, ethnicities, and genders are represented.  

Join us in fighting against colorectal cancer!
What is the purpose of the study and the blood draw?
Natera is working on an investigational (not approved for general use) blood test to find colorectal cancer in healthy volunteers. This test looks for something called DNA, which is like a set of instructions inside your body. It tells your body how to grow and work properly. This DNA is in every cell of your body. It is believed that when someone has colorectal cancer, there is more of this special DNA related to cancer in their blood. To help us learn how to detect colorectal cancer earlier, we will collect samples of blood, health information, and the results of colonoscopies (a test to check your colon) from people who are at an average risk for colorectal cancer. Average risk for colorectal cancer can be determined based on your age or your family cancer history.
What does study participation involve?
You will be a study participant for up to 12 months. The length of your study participation will depend on when you complete your colonoscopy and when the results from the colonoscopy are available to the study team.    

As a study volunteer you will be asked to provide your personal demographic and medical history by answering questions in the online participant portal. You will then be asked to complete a one time, at-home 30mL - 90mL blood draw (about 3-6 tablespoons). Then, you will attend your planned colonoscopy. Finally, you will confirm completion of the colonoscopy in the online participant portal. After this, the study team will collect your colonoscopy results from your medical provider.  

The blood draw that is collected will be used to develop Natera’s CRC blood screening test. Test results from your blood draw will not be provided to you or your local medical team.
What are the benefits and risks to participation?
You will not directly benefit from taking part in this study.  

The purpose of this study is to gather information like demographics, health history, a blood specimen and colonoscopy results from healthy volunteers. The information will be used to help develop a simple blood test. The blood test could be used in the future to screen for colorectal cancer (CRC).  

The information gained from this study may increase colorectal cancer screenings and reduce CRC death rates.  

The research team, the Sponsor and their respective representatives will take appropriate measures to maintain the privacy and security of your information; however, absolute confidentiality cannot be guaranteed. Therefore, there is a potential risk of your private information being shared or exposed while taking part in this study.
Do I need insurance?
No. Insurance is not required to participate.
Will it cost me money to participate in this research study?
It is not expected that you will have any additional costs if you join this research study.

The blood draw for the study will not be billed to you or your insurance company. However, your planned colonoscopy will not be paid for by the PROCEED-CRC study.

You will need to work with your own doctor’s office and/or insurance provider to determine the cost of your colonoscopy.

Your insurance coverage and co-pays for colonoscopy will not change if you join the study. The PROCEED-CRC study team strongly recommends that all participants contact their insurance carrier to understand all health-related costs that they may need to pay for before scheduling a colonoscopy appointment and joining the study.
Who will schedule my colonoscopy?
Please call your physician’s office (likely your primary care doctor) to schedule your colonoscopy.


Will this study impact my planned colonoscopy?
No. This study will not impact your planned colonoscopy. Please talk with your doctor if you have questions about your colonoscopy.

This study is for prospective sample-collection. Walgreens and Natera are working together to find healthy volunteers, like yourself, that already plan to complete a colonoscopy. As a healthy volunteer, you agree to volunteer your time, medical history, blood sample and colonoscopy for research. This research may be used in the future for an early colorectal cancer screening blood test.

What is an Informed Consent Form?
This form is something that all study volunteers must sign before 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.

Can I stop being in the study?
Yes. Joining a clinical research study is voluntary. If you decide at any time that you no longer want to participate in the study, you can stop.

To stop participation in the study, you will need to contact the study team by telephone toll free 1-800-371-5450 Monday – Friday between 8am – 8pm Eastern Time 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.

How will I know when, where and how to enter all of the required study information in the participant portal?
An easy to navigate participant experience is our goal! As a study volunteer, you will be guided on how to create an online participant portal. The participant portal is where you will be asked to log information and answer study related questions. You will receive email and/or text messages during the study that will help you through each step of the study.

Additionally, members of our study team will be available Monday – Friday between 8am - 8pm Eastern Time, toll free at 1-800-371-5450 if you require additional assistance.

Who can I contact if I need assistance navigating and completing question on the online participant portal?
Please contact a member of the study team toll free at 1-800-371-5450 Monday – Friday between 8am – 8pm Eastern Time and let them know you need help with the Walgreens & Natera PROCEED study.

When and how will I be paid?
Study participants will receive payment for time and effort at two timepoints in the study:
‍
- After the confirmed completion of the at-home blood draw ($75)
‍
- After the confirmed completion of scheduled colonoscopy ($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.
What if I am not comfortable with someone from Portamedic coming to my home to draw blood?
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/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 stress of 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.
In the event that my blood draw needs to be collected again, will I be paid a second time?
In the event that a repeat blood draw is necessary, you will be issued an additional electronic payment card for your time and effort.
Is the study information available in Spanish?
Yes! All study information is available in Spanish.

Walgreens and Natera 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.

If you have questions, please call us toll free at 1-800-371-5450, Monday – Friday between 8am-8pm Eastern Time if you have questions.
How can I refer friends or family members?
Spreading awareness about colorectal cancer is important. Colorectal cancer screening saves lives.

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

https://crcstudy.info/friend
Where can I learn more about clinical trials?
Please visit the following link to learn more:

https://www.walgreens.com/topic/clinical-trials.jsp
If I have additional questions, who can I ask?
We understand that any decision to participate in the study requires time to think, process and fully understand the information available 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 – Friday between 8am-8pm Eastern Time, toll free at 1-800-371-5450. A member of our team will be happy to answer your questions.

    References

    1. 1. Xi, Y.; Xu, P. Global colorectal cancerburden in 2020 and projections to 2040. TranslOncol 2021, 14 (10), 101174. DOI: 10.1016/j.tranon.2021.101174  From NLM PubMed-not-MEDLINE.
    2. Society, A. C. Cancer Facts &Figures. 2023.‍
    3. Colorectal cancer alliance. Colorectal Cancer Alliance.(2022). https://www.ccalliance.org/ ‍
    4. What is colorectal cancer? (2023) Centersfor Disease Control and Prevention. Available at:https://www.cdc.gov/cancer/colorectal/basic_info/what-is-colorectal-cancer.htm(Accessed: 21 December 2023).
    5. Siegel, R. L.; Wagle, N. S.; Cercek, A.; Smith, R. A.; Jemal, A.Colorectal cancer statistics, 2023. CA Cancer J Clin 2023, 73 (3), 233-254.DOI: 10.3322/caac.21772 From NLM Medline.‍
    6. Colon cancer treatment (2023) JohnsHopkins Medicine. Available at:https://www.hopkinsmedicine.org/health/conditions-and-diseases/colon-cancer/colon-cancer-treatment(Accessed: 21 December 2023).‍
    7. Know the warning signs of colon cancer and whento get screened(no date) Know The Warning Signs Of ColonCancer And When To Get Screened. Available at: https://intermountainhealthcare.org/blogs/know the-warning-signs-of-colon-cancer-and-when-to-get-screened(Accessed: 21 December 2023).
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