How do you keep your information about me safe and secure?

We are committed to keeping your information safe and take many measures to ensure the security of your data. Your name, address, phone number or other information that directly identifies you will never appear on any of your research data or sample(s). Rather you will be assigned a unique study number which will be linked to your research data and sample(s). Your name, address, phone number, and other information that directly identifies you will be stored in a secure electronic database and will only be available to study researchers and staff at Cleveland Clinic, Henry Ford, Mayo Clinic, Scottsdale Medical Imaging, Sarah Cannon or Sutter Health, as applicable. Information that directly identifies you will not be sent outside of Cleveland Clinic, Henry Ford, Mayo Clinic, Scottsdale Medical Imaging, Sarah Cannon or Sutter Health, to researchers at GRAIL, Inc. or other collaborating centers. Any genomic information obtained as a part of the STRIVE Study will not be linked to your name or other information that directly identifies you. All study staff are trained in confidentiality to minimize risk.

What if I change my mind about participation in the future?

You have the right to withdraw from the study at any time.  Please contact the institution you enrolled at for more information.

How can I stay involved in STRIVE?

Enrollment in the STRIVE Study entails the completion of an informed consent form and a health questionnaire, and the submission of a blood sample at the time of your mammogram or within 28 days. After you have been successfully enrolled in the STRIVE Study, study investigators will follow your health for up to 5 years by reviewing your electronic health records. During that time it will be important for you to let study personnel know if you have diagnostic work-up or are diagnosed with cancer outside of your health clinic (Cleveland Clinic, Henry Ford, Mayo Clinic, Scottsdale Medical Imaging, Sarah Cannon, or Sutter Health).

How long will you be monitoring my electronic health record?

We will be actively monitoring your electronic health record for health information for up to 5 years after your enrollment in the STRIVE Study. The types of information we will monitor may include: medical lists, medical history, doctor progress notes, discharge summaries, and all test results including genetic test results (no HIV test results). After the five-year follow-up period we will follow your health status indirectly for up to 75 years by linking your information with state and national health databases.

What exactly will you do with the genomic information from my blood sample and/or any genomic testing information from my medical record?

As part of the STRIVE Study, genomic material such as DNA will be isolated. We will look for particular markers or sequences that might be relevant for the detection of cancer. To develop our test, we will combine genomic findings from the blood samples with information from the medical records. Findings will be reported as a group only; no individual will ever be identified by name.

Will my sample be used to study any other medical conditions, in addition to cancer?

The STRIVE Study’s purpose is to evaluate a blood test that may help detect cancer early. Data collected as part of the STRIVE Study may also be used to research other health conditions.

What does STRIVE stand for?

The STRIVE Study captures the spirit of the joint effort between researchers, healthcare providers and women like you to evaluate an additional tool for the early detection of cancer. STRIVE is not an acronym.

Whom should I contact if I did not receive my gift?

If it has been at least 30 days since you have completed your blood draw and questionnaire or if you provide an additional blood draw and you have not received your gift, please contact:

Is my blood going to be shared for use in other studies?

We may share the blood samples and data collected for research purposes (for example, your questionnaire results, diagnosis, outcome, or treatment information) with other researchers, institutions and companies that provide services to, are affiliated with, or collaborate with Cleveland Clinic, Henry Ford, Mayo Clinic, Scottsdale Medical Imaging, Sarah Cannon, Sutter Health and GRAIL, Inc. However, we will not share your name, address, phone number, or any other information that would directly identify you. Samples and data from which your directly identifying information has been removed may be used for other research purposes or shared with other researchers after obtaining any necessary approvals.

What are you doing with my blood?

All blood samples will be stored in locked freezers in a laboratory associated with GRAIL, Inc. As this is a research study, certain samples will be thawed and analyzed according to research goals and timelines. Some blood samples will be sequenced immediately, while others will be analyzed at a later time. Regardless, every sample is vital to the success of the STRIVE Study and development of blood tests for early cancer detection.

How many times do I have to give blood?

Study participation involved you already giving a blood sample once, at the time of your screening mammogram. Some women will be asked to provide additional blood samples at a later date based on the results of their mammogram or other events.

Do I need to fast or follow any special instructions before the blood is drawn?

No, there is no need to fast or follow any special instructions prior to this blood collection.

How much blood are you going to draw?

We will collect 4 tubes (about 40mL or 3 tablespoons) of blood.    

How long will the blood collection take?

The blood draw will take no more than 15 minutes and will include 4 tubes (about 40 mL or 3 tablespoons) of blood. The blood sample will be collected by a trained and certified phlebotomist. (A phlebotomist is someone who has been trained to collect blood samples from people.) We will do everything we can to make the blood collection process as quick and comfortable as possible.

If I have questions, or if I have been contacted about the study and do not wish to receive any further communication, whom can I contact?

Cleveland Clinic participants: email strive@ccf.org or call 1-844-978-7483

Henry Ford participants: email strive@hfhs.org or call 1-833-378-7483

Mayo Clinic participants: email strive@mayo.edu or call 1-844-366-9738

Sarah Cannon participants: email strive@sarahcannon.com or call 1-833-478-7483

Scottsdale Medical Imaging participants: email strive@esmil.com or call 1-480-425-4170

Sutter Health participants: email strive@sutterhealth.org or call 1-855-5-STRIVE

How will my information be used?

We will combine analysis of the blood sample with information from your medical record and health history. The results will be analyzed together with the results of other women participating in the study. Findings will be reported as a group only; no individual will ever be identified by name. 

Will I get my results?

No, neither you nor your doctor will receive any personal test results because the test is still under development and is not validated. This study aims to evaluate the ability of the test to detect cancer early. Until all the required data are collected and analyzed, we will not know whether the test can do that. The test must be fully evaluated before it can be used to aid in decision making about your health care.

How did you get my contact information?

We received your contact information because you had an appointment for a mammogram at a Cleveland Clinic, Henry Ford, Mayo Clinic, Sarah Cannon, Scottsdale Medical Imaging or Sutter Health center.

Who is funding the study?

The STRIVE Study is funded by GRAIL, Inc., a healthcare company located in Menlo Park, CA that is focused on the development of screening tests for early detection of cancer. The study involves researchers from Cleveland Clinic, Henry Ford, Mayo Clinic, Sarah Cannon, Scottsdale Medical Imaging and Sutter Health.

Can you tell me more about this study?

The purpose of the STRIVE Study is to validate a test designed to detect multiple cancers at early stages. This blood test looks for small pieces of DNA (genomic material) released into the blood by tumors. More tools are needed in order to detect cancer early. This study will look at whether a blood test can enhance the early detection of cancer.
The study asked women to provide a blood sample at the same visit as their regular screening mammogram, or at another convenient time within 28 days of their mammogram appointment. Participants were also asked to complete a 20-minute questionnaire about their health.
Information about the participants’ medical care will be collected for up to 5 years from their enrollment date. After that, their health status will be followed indirectly by linking participants’ information with state and national health databases to capture clinical outcome data, including cancer diagnoses.

Can you tell me more about how the blood test works?

Cancers involve a change in the genes of the cells in one of the body’s organs or tissues. The change leads to abnormal growth causing a tumor mass. These tumor cells release small pieces of genomic material such as DNA, into the blood,  called circulating tumor nucleic acid (ctNA). Genomic sequencing involves the study of nucleic acids isolated from cells in the body. In this case, genomic sequencing of the cfNA from the blood sample is used to find  changes in the genome that indicate the presence of cancer.

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