AI-EMERGE: Development and Validation of a Multi-analyte, Blood-based Colorectal Cancer Screening Test

Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in blood to detect cancer early. The purpose of this study is to develop and validate a blood-based assay to detect colorectal cancer by collecting blood and stool samples from healthy patients undergoing routine screening colonoscopy and from patients recently diagnosed with colorectal cancer or advanced adenomas.

Early detection of cancer combined with effective treatment improves survival and quality of life. Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in the blood to detect cancer early. The purpose of this study is to develop and validate a blood-based assay for the early detection of colorectal cancer. The study will collect blood and stool samples from healthy patients undergoing routine screening colonoscopy and from patients recently diagnosed with colorectal cancer or advanced adenomas. A blood-based test for colorectal cancer and pre-cancerous lesions could offer an accurate, convenient, and patient-friendly screening option for current and future generations, and, in doing so, could save and improve lives by increasing adherence and early detection.

Freenome is looking for three types of patients in this study:

Cohort A:

People ages 50-84 who have been recently diagnosed with (or strong clinical suspicion for) colorectal cancer or advanced adenoma. Blood samples must be collected before any cancer treatment has been initiated.

Cohort B:

People ages 50-84 undergoing routine screening colonoscopies for colorectal cancer as part of their regular medical check-ups. Blood samples must be collected before bowel preparation for the colonoscopy.

Cohort C:

People 18 years or older who have been recently diagnosed with (or strong clinical suspicion for) colorectal cancer or advanced adenoma. Blood samples must be collected before any cancer treatment has been initiated.

Eligibility Criteria:
COHORT A

Inclusion Criteria:

* 50-84 years of age (inclusive) at the time of screening
* Recently diagnosed with (or strong clinical suspicion for) primary colorectal cancer or advanced adenoma with plans to surgically or endoscopically remove the target lesion(s)
* At least 7 days before but no more than 6 months after the most recent colonoscopy
* Able and willing to provide blood and stool (optional) samples per protocol
* Able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study

Key Exclusion Criteria:

* Personal history of colorectal cancer, colorectal adenomas (excluding non-adenomatous (e.g., hyperplastic polyps)) or aerodigestive tract cancer (other than most recent diagnosis)
* Colonoscopy within the previous 9 years (other than most recent diagnosis)
* Overt rectal bleeding within the previous 30 days
* Have a medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
* Have participated or be currently participating in a clinical research study in which an experimental medication has been administered during the 60 days up to and including the date of providing informed consent or may be administered through the time of the colonoscopy.
* If female, known to be pregnant.

COHORT B

Inclusion Criteria:

* 50-84 years of age (inclusive) at the time of screening
* Planning to undergo a screening colonoscopy within 75 days after providing signed informed consent
* Able and willing to provide blood and stool (optional) samples per protocol
* Able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study

Key Exclusion Criteria:

* Personal history of colorectal cancer, colorectal adenoma (excluding non-adenomatous (e.g., hyperplastic polyps)) or aerodigestive tract cancer
* Colonoscopy within the previous 9 years
* Overt rectal bleeding within the previous 30 days
* Have a medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
* Have participated or be currently participating in a clinical research study in which an experimental medication has been administered during the 60 days up to and including the date of providing informed consent or may be administered through the time of the colonoscopy.
* If female, known to be pregnant.

COHORT C

Inclusion Criteria:

* At least 18 years of age (inclusive) at the time of screening
* Recently diagnosed with (or strong clinical suspicion for) primary colorectal cancer or advanced adenoma with plans to surgically or endoscopically remove the target lesion(s)
* At least 7 days before but no more than 6 months after the most recent colonoscopy
* Able and willing to provide blood and stool (optional) samples per protocol
* Able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study

Exclusion Criteria:

* Have a medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
* Have participated or be currently participating in a clinical research study in which an experimental medication has been administered during the 60 days up to and including the date of providing informed consent or may be administered through the time of the colonoscopy.
* If female, be known to be pregnant.