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

Specimen Collection Study for Cancer

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.

Study Overview

• Status: Completed
• Conditions: Adenoma; Polyps; Cancer, Rectum; Polyp of Colon; Colo-rectal Cancer; Adenoma Colon; Neoplasms,Colorectal; Cancer Colon

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
• Enrollment (Actual): 3275

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Forzani and MacPhail Colon Cancer Screening Centre
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Clinical Research Associates
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Del Sol Research Management
    • Tucson, Arizona, United States, 85710
      • Del Sol Research Management,
    • Tucson, Arizona, United States, 85745
      • Del Sol Research Management
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Preferred Research Partners
  • California
    • Chula Vista, California, United States, 91910
      • Precision Research Institute
    • Oxnard, California, United States, 93030
      • Diverse Research Solutions
    • San Diego, California, United States, 92114
      • Precision Research Institute
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • Gastroenterology Associates of Fairfield County
  • Florida
    • Hialeah, Florida, United States, 33016
      • Palmetto Research
    • Homestead, Florida, United States, 33030
      • Clinical Research of Homestead
    • Palm Harbor, Florida, United States, 34684
      • Advanced Gastroenterology Associates, LLC
  • Illinois
    • Rockford, Illinois, United States, 61107
      • Rockford Gastroenterology
  • Louisiana
    • Bastrop, Louisiana, United States, 71220
      • Delta Research Partners
    • Metairie, Louisiana, United States, 70006
      • New Orleans Research Institute
    • Shreveport, Louisiana, United States, 71105
      • Louisiana Research Center
  • Massachusetts
    • Brockton, Massachusetts, United States, 02302
      • Commonwealth Clinical Studies
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Asheville Gastroenterology Associates
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
    • Fayetteville, North Carolina, United States, 28304
      • Cumberland Research Associates
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
    • Wilmington, North Carolina, United States, 28403
      • Trial Management Associates
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • The Jackson Clinic
  • Utah
    • Ogden, Utah, United States, 84405
      • Advanced Research Institute
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Gastroenterology Associates of Tidewater
    • Fairfax, Virginia, United States, 22031
      • Verity Research Inc
    • Norfolk, Virginia, United States, 23502
      • Digestive and Liver Disease Specialists
  • Washington
    • Bellevue, Washington, United States, 98004
      • Washington Gastroenterology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of colorectal cancer or advanced adenomas in patients undergoing routine screening colonoscopy, or post-colonoscopy	Clinically annotated plasma samples from participants will undergo multi-omic analyses to characterize cell-free biomarkers.	6 months

Collaborators and Investigators

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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2018
• Primary Completion (Actual): November 25, 2019
• Study Completion (Actual): November 25, 2019

Study Registration Dates

• First Submitted: August 27, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (Actual): September 28, 2018

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Genomics; Liquid biopsy; CRC; Blood test cancer; Cancer diagnostic; Genomic test; AI genomics; Cancer screening
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Intestinal Polyps; Colorectal Neoplasms; Adenoma; Rectal Neoplasms; Polyps; Colonic Polyps
• Other Study ID Numbers: AI-EMERGE/FRE-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No