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

Sponsor

Freenome Holdings Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03688906

Collaborator

(none)

3,275

Enrollment

Locations

22.4

Actual Duration (Months)

109.2

Patients Per Site

4.9

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

3275 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Specimen Collection Study for Cancer

Actual Study Start Date :

Jan 12, 2018

Actual Primary Completion Date :

Nov 25, 2019

Actual Study Completion Date :

Nov 25, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Associates	Huntsville	Alabama	United States	35801
2	Del Sol Research Management	Chandler	Arizona	United States	85224
3	Del Sol Research Management,	Tucson	Arizona	United States	85710
4	Del Sol Research Management	Tucson	Arizona	United States	85745
5	Preferred Research Partners	Little Rock	Arkansas	United States	72211
6	Precision Research Institute	Chula Vista	California	United States	91910
7	Diverse Research Solutions	Oxnard	California	United States	93030
8	Precision Research Institute	San Diego	California	United States	92114
9	Gastroenterology Associates of Fairfield County	Bridgeport	Connecticut	United States	06606
10	Palmetto Research	Hialeah	Florida	United States	33016
11	Clinical Research of Homestead	Homestead	Florida	United States	33030
12	Advanced Gastroenterology Associates, LLC	Palm Harbor	Florida	United States	34684
13	Rockford Gastroenterology	Rockford	Illinois	United States	61107
14	Delta Research Partners	Bastrop	Louisiana	United States	71220
15	New Orleans Research Institute	Metairie	Louisiana	United States	70006
16	Louisiana Research Center	Shreveport	Louisiana	United States	71105
17	Commonwealth Clinical Studies	Brockton	Massachusetts	United States	02302
18	Quality Clinical Research	Omaha	Nebraska	United States	68114
19	Asheville Gastroenterology Associates	Asheville	North Carolina	United States	28801
20	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599
21	Cumberland Research Associates	Fayetteville	North Carolina	United States	28304
22	Wake Research Associates	Raleigh	North Carolina	United States	27612
23	Trial Management Associates	Wilmington	North Carolina	United States	28403
24	The Jackson Clinic	Jackson	Tennessee	United States	38305
25	Advanced Research Institute	Ogden	Utah	United States	84405
26	Gastroenterology Associates of Tidewater	Chesapeake	Virginia	United States	23320
27	Verity Research Inc	Fairfax	Virginia	United States	22031
28	Digestive and Liver Disease Specialists	Norfolk	Virginia	United States	23502
29	Washington Gastroenterology	Bellevue	Washington	United States	98004
30	Forzani and MacPhail Colon Cancer Screening Centre	Calgary	Alberta	Canada	T2N 4Z6