CORRECT-MRD II: What does participating involve for me?

Your participation in this study will last up to 7 years. This will include up to 15 study visits to the study center at routine scheduled follow-up visit times.

Before any study-related tests and procedures are performed, you will be asked to read, sign, and date a consent form and an Authorization to Use and Disclose Protected Health Information form.

If you agree to participate, the study doctor and study staff will check if you qualify to take part in the study. They will do this in part by reviewing your existing medical record. You will also be asked to answer demographic and health questions to determine if you qualify to take part in this study:

• Demographic Questions: You will be asked about your personal information, such as your name, date of birth, gender, race, and ethnicity
• Health Questions: You will be asked about your medical history. This will include your recent medications, cancer diagnose(s), and other questions about your health history

After the study doctor or study staff confirm you meet all the criteria to be part of this study, you will be asked to have the following completed:

• Height and Weight: Your height and weight will be measured
• Blood sample: The study staff will collect blood from you (approximately 8 ½ teaspoons) up to 15 times at the following timepoints:
  
  • Baseline (v01, your initial visit): A baseline collection will occur between 14 to 180 days following your surgery and prior to starting any other therapy. If an issue arises in which the sample you provide is unusable, you may be asked to have the sample redrawn
  • Follow Up (v02-v15): Sample collection will occur every 90 days +/- 30 days after baseline for up to two years or until your cancer returns. If your cancer does not return within two years, you will continue with blood draws every 180 days +/- 30 days until 5 years of total follow-up has been reached, your cancer returns, or the study ends
  • Clinical Recurrence (vR): Patients who have a confirmed clinical recurrence while participating in this study will have blood drawn within 60 days after confirmation of recurrence and prior to initiation of therapy for recurrence
• Tissue sample: Tissue from your biopsy or surgical resection will be sent to Exact Sciences by the study team for use in the Exact MRD and Oncotype DX tests. This tissue will be sent from an existing sample, another surgery will not be required. If there is an issue with the sample provided, additional tissue from the existing sample may be sent
  • The Exact MRD test is being done for investigational purposes only. You and your treating physician will not receive the Exact MRD test results
  • Your treating physician will receive the results of the Oncotype DX test if your cancer is colon cancer (not rectal cancer), and your cancer is Stage II – IIIC. If your cancer does not meet those criteria, your treating physician will not receive the results of the Oncotype DX test. This is because the Oncotype DX test is only validated for these types of cancer. Unvalidated results cannot be shared or used to determine treatment. Your treating physician will discuss with you whether you will receive the results of this test or not. For more information on the Oncotype DX test (including sample reports) please visit: https://precisiononcology.exactsciences.com/healthcare-providers/treatment-determination/colon-cancer/oncotype-dx-colon-recurrence-score/explore-the-results
• If you have a confirmed recurrence while participating in this study and a biopsy or surgery is needed, a sample of the tissue collected at that time will also be sent to Exact Sciences for testing
  • The OncoExTra™ test will be performed on your initial and any recurrent tumor tissue samples (if available). OncoExTra is a comprehensive genomic profiling test that may inform treatment decisions about your recurrence. If recurrent tumor tissue is available to submit, the results from the recurrent tumor tissue will be provided to your treating physician. If recurrent tissue is not available to submit, the initial tumor tissue sample may be used and the results from the initial tumor tissue will be provided to your treating physician. For more information on the OncoExTra test, please visit: https://precisiononcology.exactsciences.com/healthcare-providers/therapy-selection/advanced-solid-tumors/oncoextra
• Saliva sample: If you experience a clinical recurrence while on this study, the study staff may collect a saliva sample from you (approximately ½ a teaspoon). The saliva sample will be collected if there is a tissue sample of your recurrence available. The saliva sample may also be collected if a tissue sample is not available for the recurrence, but there is adequate tissue available from the initial tissue sample. The saliva sample and tissue sample will be used to perform the OncoExTra test as described above. The saliva sample is needed to perform a “germline subtraction.” This means that your normal DNA will be assessed, and removed from the analysis, so the test can better detect cancer DNA

Once you have completed five years of clinical follow up, or have had a recurrence (i.e, your cancer has returned), your study participation will be complete. If your cancer returns while you are on this study, Exact Sciences will continue to collect data from you or your medical record for an additional two years after the blood sample collections are complete. If you withdraw consent for blood sample collections, Exact Sciences will continue to collect data from you or your medical record for one additional year after your last blood sample collection. If you are on this study and do not have a blood draw completed for 18 months due to missed blood collection timepoints, you will be withdrawn from the study and no further follow up data will be collected for the study.