ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03688906
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Freenome, Inc.

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.

Condition or disease
Colo-rectal Cancer Cancer Colon Cancer, Rectum Neoplasms,Colorectal Polyps Polyp of Colon Adenoma Adenoma 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 [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Specimen Collection Study for Cancer
Actual Study Start Date : January 12, 2018
Estimated Primary Completion Date : March 29, 2019
Estimated Study Completion Date : March 29, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688906


Contacts
Contact: Carolina Sheridan 650-446-6630 clinicalstudy@freenome.com

  Hide Study Locations
Locations
United States, Alabama
Clinical Research Associates Terminated
Huntsville, Alabama, United States, 35801
United States, Arizona
Del Sol Research Management Recruiting
Chandler, Arizona, United States, 85224
Principal Investigator: Tushar Gohel, M.D.         
Del Sol Research Management, Recruiting
Tucson, Arizona, United States, 85710
Principal Investigator: Gary Gottlieb, M.D.         
Del Sol Research Management Recruiting
Tucson, Arizona, United States, 85745
Principal Investigator: Rizwan Safdar, M.D.         
United States, Arkansas
Preferred Research Partners Terminated
Little Rock, Arkansas, United States, 72211
United States, California
Precision Research Institute Recruiting
Chula Vista, California, United States, 91910
Principal Investigator: Cynthia Schaeffer, M.D.         
Diverse Research Solutions Recruiting
Oxnard, California, United States, 93030
Principal Investigator: Karen Simon, M.D.         
Precision Research Institute Recruiting
San Diego, California, United States, 92114
Principal Investigator: Taddese Desta, M.D.         
United States, Connecticut
Gastroenterology Associates of Fairfield County Recruiting
Bridgeport, Connecticut, United States, 06606
Principal Investigator: Strick Woods, M.D.         
United States, Florida
Palmetto Research Recruiting
Hialeah, Florida, United States, 33016
Principal Investigator: Jeffrey Gonzalez, M.D.         
Clinical Research of Homestead Recruiting
Homestead, Florida, United States, 33030
Principal Investigator: Michael Feldman, M.D.         
Advanced Gastroenterology Associates, LLC Recruiting
Palm Harbor, Florida, United States, 34684
Principal Investigator: Jawahar Taunk, M.D.         
United States, Illinois
Rockford Gastroenterology Recruiting
Rockford, Illinois, United States, 61107
Principal Investigator: Sunil Patel, M.D.         
United States, Louisiana
Delta Research Partners Recruiting
Bastrop, Louisiana, United States, 71220
Principal Investigator: Bal Raj Bhandari, M.D.         
New Orleans Research Institute Recruiting
Metairie, Louisiana, United States, 70006
Principal Investigator: George Catinis, M.D.         
Louisiana Research Center Recruiting
Shreveport, Louisiana, United States, 71105
Principal Investigator: Humberto Aguilar, M.D.         
United States, Massachusetts
Commonwealth Clinical Studies Recruiting
Brockton, Massachusetts, United States, 02302
Principal Investigator: Jerry Stern, M.D.         
United States, Nebraska
Quality Clinical Research Recruiting
Omaha, Nebraska, United States, 68114
Principal Investigator: Charles Ternent, M.D.         
United States, North Carolina
Asheville Gastroenterology Associates Terminated
Asheville, North Carolina, United States, 28801
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Principal Investigator: Seth Crockett, M.D.         
Cumberland Research Associates Recruiting
Fayetteville, North Carolina, United States, 28304
Principal Investigator: Valli Kodali, M.D.         
Wake Research Associates Recruiting
Raleigh, North Carolina, United States, 27612
Principal Investigator: Charles Barish, M.D.         
Trial Management Associates Recruiting
Wilmington, North Carolina, United States, 28403
Principal Investigator: Steven Klein, M.D.         
United States, Tennessee
The Jackson Clinic Recruiting
Jackson, Tennessee, United States, 38305
Principal Investigator: Ami Naik, M.D.         
United States, Utah
Advanced Research Institute Recruiting
Ogden, Utah, United States, 84405
Principal Investigator: John Lowe, M.D.         
United States, Virginia
Gastroenterology Associates of Tidewater Recruiting
Chesapeake, Virginia, United States, 23320
Principal Investigator: Felix Tiongco, M.D.         
Verity Research Inc Recruiting
Fairfax, Virginia, United States, 22031
Principal Investigator: Bezawit Tekola, M.D.         
Digestive and Liver Disease Specialists Recruiting
Norfolk, Virginia, United States, 23502
Principal Investigator: David Johnson, M.D.         
United States, Washington
Washington Gastroenterology Recruiting
Bellevue, Washington, United States, 98004
Principal Investigator: Robert Wohlman, M.D.         
Canada, Alberta
Forzani and MacPhail Colon Cancer Screening Centre Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Principal Investigator: Robert Hilsden, M.D.         
Sponsors and Collaborators
Freenome, Inc.
Investigators
Study Director: Girish Putcha, M.D., Ph.D Freenome, Inc.

Responsible Party: Freenome, Inc.
ClinicalTrials.gov Identifier: NCT03688906     History of Changes
Other Study ID Numbers: AI-EMERGE/FRE-001
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018

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

Keywords provided by Freenome, Inc.:
Liquid biopsy
Blood test cancer
Cancer diagnostic
Genomics
Genomic test
AI genomics
CRC
Cancer screening

Additional relevant MeSH terms:
Polyps
Adenoma
Colorectal Neoplasms
Colonic Polyps
Rectal Neoplasms
Pathological Conditions, Anatomical
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Polyps