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

Colo-rectal Cancer Clinical Trial

Official title:

Specimen Collection Study for Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03688906
• Other study ID #: AI-EMERGE/FRE-001
• Status: Completed
• Start date: January 12, 2018
• Est. completion date: November 25, 2019

Study information

• Verified date: February 2022
• Source: Freenome Holdings Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3275
• Est. completion date: November 25, 2019
• Est. primary completion date: November 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Canada	Forzani and MacPhail Colon Cancer Screening Centre	Calgary	Alberta
United States	Asheville Gastroenterology Associates	Asheville	North Carolina
United States	Delta Research Partners	Bastrop	Louisiana
United States	Washington Gastroenterology	Bellevue	Washington
United States	Gastroenterology Associates of Fairfield County	Bridgeport	Connecticut
United States	Commonwealth Clinical Studies	Brockton	Massachusetts
United States	Del Sol Research Management	Chandler	Arizona
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Gastroenterology Associates of Tidewater	Chesapeake	Virginia
United States	Precision Research Institute	Chula Vista	California
United States	Verity Research Inc	Fairfax	Virginia
United States	Cumberland Research Associates	Fayetteville	North Carolina
United States	Palmetto Research	Hialeah	Florida
United States	Clinical Research of Homestead	Homestead	Florida
United States	Clinical Research Associates	Huntsville	Alabama
United States	The Jackson Clinic	Jackson	Tennessee
United States	Preferred Research Partners	Little Rock	Arkansas
United States	New Orleans Research Institute	Metairie	Louisiana
United States	Digestive and Liver Disease Specialists	Norfolk	Virginia
United States	Advanced Research Institute	Ogden	Utah
United States	Quality Clinical Research	Omaha	Nebraska
United States	Diverse Research Solutions	Oxnard	California
United States	Advanced Gastroenterology Associates, LLC	Palm Harbor	Florida
United States	Wake Research Associates	Raleigh	North Carolina
United States	Rockford Gastroenterology	Rockford	Illinois
United States	Precision Research Institute	San Diego	California
United States	Louisiana Research Center	Shreveport	Louisiana
United States	Del Sol Research Management	Tucson	Arizona
United States	Del Sol Research Management,	Tucson	Arizona
United States	Trial Management Associates	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Freenome Holdings Inc.

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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