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

• ClinicalTrials.gov Identifier: NCT03688906
• Recruitment Status: Completed
• First Posted: September 28, 2018
• Last Update Posted: March 2, 2022
• Sponsor: Freenome Holdings Inc.
• Information provided by (Responsible Party): Freenome Holdings Inc.

Tracking Information

• First Submitted Date: August 27, 2018
• First Posted Date: September 28, 2018
• Last Update Posted Date: March 2, 2022
• Actual Study Start Date: January 12, 2018
• Actual Primary Completion Date: November 25, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 26, 2018)

Diagnosis of colorectal cancer or advanced adenomas in patients undergoing routine screening colonoscopy, or post-colonoscopy [ Time Frame: 6 months ]

Clinically annotated plasma samples from participants will undergo multi-omic analyses to characterize cell-free biomarkers.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: AI-EMERGE: Development and Validation of a Multi-analyte, Blood-based Colorectal Cancer Screening Test
• Official Title: Specimen Collection Study for Cancer
• Brief Summary: 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.

Detailed Description

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.

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Other; Time Perspective: Prospective
• Target Follow-Up Duration: 6 Months
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample

Study Population

Subjects for the study will be enrolled into three cohorts:

• 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.

Condition

• Colo-rectal Cancer
• Cancer Colon
• Cancer, Rectum
• Neoplasms,Colorectal
• Polyps
• Polyp of Colon
• Adenoma
• Adenoma Colon

• Intervention: Not Provided

Study Groups/Cohorts

• Cohort A

  Blood and stool specimen collection.

  Study samples must be collected prior to any treatment.

• Cohort B

  Blood and stool specimen collection.

  Samples must be collected prior to performing bowel preparation for the colonoscopy.

• Cohort C

  Blood and stool specimen collection.

  Study samples must be collected prior to any treatment.

• Publications *: Putcha G, Liu T-Y, Ariazi E, Bertin M, Drake A, Dzamba M, Hogan G, Kothen-Hill S, Liao J, Li K, Mahajan S, Palaniappan K, Sansanwal P, St John J, Ulz P, Wan N, Warsinske H, Weinberg D, Yang R, Lin J. Blood-based detection of early-stage colorectal cancer using multiomics and machine learning. [Abstract] J Clin Oncol 38 (Suppl 4): A-66, 2020.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 13, 2020): 3275
• Original Estimated Enrollment (submitted: September 26, 2018): 3000
• Actual Study Completion Date: November 25, 2019
• Actual Primary Completion Date: November 25, 2019 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT03688906
• Other Study ID Numbers: AI-EMERGE/FRE-001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Freenome Holdings Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Freenome Holdings Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Girish Putcha, M.D., Ph.D; Freenome Holdings Inc.

• PRS Account: Freenome Holdings Inc.
• Verification Date: February 2022