Specimen Collection Study for Cancer
Trial ID: NCT03688906
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2018-01-12
Completion date: 2019-11-25
Sponsor: Freenome Holdings Inc.
Conditions: Colo-rectal Cancer; Cancer Colon; Cancer, Rectum; Neoplasms,Colorectal; Polyps; Polyp of Colon; Adenoma; Adenoma Colon
Locations: Clinical Research Associates; Del Sol Research Management; Del Sol Research Management,; Del Sol Research Management; Preferred Research Partners; Precision Research Institute; Diverse Research Solutions; Precision Research Institute; Gastroenterology Associates of Fairfield County; Palmetto Research; Clinical Research of Homestead; Advanced Gastroenterology Associates, LLC; Rockford Gastroenterology; Delta Research Partners; New Orleans Research Institute; Louisiana Research Center; Commonwealth Clinical Studies; Quality Clinical Research; Asheville Gastroenterology Associates; University of North Carolina at Chapel Hill; Cumberland Research Associates; Wake Research Associates; Trial Management Associates; The Jackson Clinic; Advanced Research Institute; Gastroenterology Associates of Tidewater; Verity Research Inc; Digestive and Liver Disease Specialists; Washington Gastroenterology; Forzani and MacPhail Colon Cancer Screening Centre
Countries: United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; Canada
Enrollment: 3275
Age range: 18 Years - None
Sex: ALL

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.

Eligibility 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.

Outcomes:
Diagnosis of colorectal cancer or advanced adenomas in patients undergoing routine screening colonoscopy, or post-colonoscopy