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



Status:Recruiting
Conditions:Colorectal Cancer, Colorectal Cancer, Cancer, Lymphoma, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:18 - Any
Updated:12/16/2018
Start Date:January 12, 2018
End Date:March 29, 2019
Contact:Carolina Sheridan
Email:clinicalstudy@freenome.com
Phone:650-446-6630

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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.

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.

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.
We found this trial at
29
sites
3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Principal Investigator: Charles Barish, M.D.
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Seth Crockett, M.D.
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
Principal Investigator: Felix Tiongco, M.D.
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Asheville, North Carolina 28801
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Bastrop, Louisiana 71220
Principal Investigator: Bal Raj Bhandari, M.D.
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Bellevue, Washington 98004
Principal Investigator: Robert Wohlman, M.D.
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Bridgeport, Connecticut 06606
Principal Investigator: Strick Woods, M.D.
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Brockton, Massachusetts 02302
Principal Investigator: Jerry Stern, M.D.
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Calgary, Alberta
Principal Investigator: Robert Hilsden, M.D.
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850 North Kolb Road
Chandler, Arizona 85224
Principal Investigator: Tushar Gohel, M.D.
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Chula Vista, California 91910
Principal Investigator: Cynthia Schaeffer, M.D.
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Fairfax, Virginia 22031
Principal Investigator: Bezawit Tekola, M.D.
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Fayetteville, North Carolina 28304
Principal Investigator: Valli Kodali, M.D.
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Hialeah, Florida 33016
Principal Investigator: Jeffrey Gonzalez, M.D.
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Homestead, Florida 33030
Principal Investigator: Michael Feldman, M.D.
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Huntsville, Alabama 35801
Principal Investigator: C. Allen Goetsch, M.D.
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Jackson, Tennessee 38301
Principal Investigator: Ami Naik, M.D.
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Little Rock, Arkansas 72211
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Metairie, Louisiana 70006
Principal Investigator: George Catinis, M.D.
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Norfolk, Virginia 23502
Principal Investigator: David Johnson, M.D.
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Ogden, Utah 84405
Principal Investigator: John Lowe, M.D.
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10040 Regency Cir
Omaha, Nebraska 68114
(402) 934-0044
Principal Investigator: Charles Ternent, M.D.
Quality Clinical Research, Inc. Welcome to Quality Clinical Research. We originated here in Omaha, NE...
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Oxnard, California 93030
Principal Investigator: Karen Simon, M.D.
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Palm Harbor, Florida 34684
Principal Investigator: Jawahar Taunk, M.D.
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Rockford, Illinois 61107
Principal Investigator: Sunil Patel, M.D.
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San Diego, California 92115
Principal Investigator: Taddese Desta, M.D.
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Shreveport, Louisiana 71103
Principal Investigator: Humberto Aguilar, M.D.
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Tucson, Arizona 85710
Principal Investigator: Rizwan Safdar, M.D.
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Wilmington, North Carolina 28403
Principal Investigator: Steven Klein, M.D.
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