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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03688906
Other study ID # AI-EMERGE/FRE-001
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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