Sample Collection Study for the CellMax Life Circulating Tumor Cell and Circulating Tumor DNA Platforms for the Early Detection of Colorectal Cancer and Adenomas

Study Overview
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Brief Summary
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The purpose of this study is to collect clinical specimens from subjects with a diagnosis of colorectal cancer/advanced adenoma or undergoing a screening colonoscopy and meeting study eligibility criteria.

Official Title
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Sample Collection Study for the CellMax Life Circulating Tumor Cell and Circulating Tumor DNA Platforms for the Early Detection of Colorectal Cancer and Adenomas

Conditions
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Colorectal Cancer Screening

Intervention / Treatment
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* Diagnostic Test: FirstSight blood test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To enroll in Cohort A, a subject must: Be 45-80 years of age (inclusive) at the time of screening. Be recently diagnosed with primary colorectal cancer or advanced adenoma with plans to surgically remove the target lesion. To enroll in Cohort B, a subject must: Be 45-80 years of age (inclusive) at the time of screening. Be planning to undergo a screening colonoscopy within 30 days after providing signed informed consent. Exclusion Criteria: To enroll in Cohort A, a subject must NOT have: Inflammatory bowel disease (IBD) Personal or family history of colorectal cancer syndromes or other hereditary cancer syndromes To enroll in Cohort B, a subject must NOT have: Personal history of colorectal cancer, colorectal adenoma or aerodigestive tract cancer. Personal or family history of Familial adenomatous polyposis (FAP). Personal or family history of Hereditary non-polyposis colorectal cancer syndrome (HNPCC or Lynch Syndrome). Positive fecal occult blood testing (FOBT) within the previous 6 months. Positive fecal immunochemical testing (FIT) in the previous 6 months. Colorectal resection for any reason other than sigmoid diverticular disease. Overt rectal bleeding within the previous 30 days. Personal history of any cancer diagnosed <5 years prior. Inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and Crohn's disease. Colonoscopy within the previous 9 years. Barium enema, computed tomographic colonography, or sigmoidoscopy within the previous 5 years. ≥ 2 first-degree relatives who have been diagnosed with colorectal cancer (Note: First degree relatives include parents, siblings and offspring). 1 first-degree relative with CRC diagnosed before the age of 60. Have participated or be currently participating in a clinical research study in which an experimental medication has been administered during the 30 days up to and including the date of providing informed consent or may be administered through the time of the colonoscopy. Have a medical condition which, in the opinion of the investigator, should preclude enrollment into the study.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A<br>Cohort A will include subjects with a recent diagnosis of colorectal cancer and/or advanced adenoma requiring additional endoscopic or surgical resection (surgery). | Diagnostic Test: FirstSight blood test<br>* FirstSight blood test for colorectal cancer screening<br>|
| Cohort B<br>Cohort B will include subjects undergoing routine screening colonoscopies will be enrolled in the screening cohort. | Diagnostic Test: FirstSight blood test<br>* FirstSight blood test for colorectal cancer screening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity for CRC of the FirstSight test |  | 30 days | 
| Specificity of the FirstSight test |  | 30 days |