Phase
Condition
Colon Cancer Screening
Treatment
N/AClinical Study ID
Ages > 40 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
40 years of age or older at time of consent.
Planning or intending to undergo asymptomatic screening colonoscopy.
Able to tolerate venipuncture for research draw(s).
Able and willing to provide blood samples within the 120 days prior to a colonoscopyprocedure.
Willing and able to comply with the study visit schedule and study requirements.
Signed informed consent(s) must be obtained prior to participation in the study
Exclusion
Exclusion Criteria:
Any prior history of any kind of malignancy (exception: participants who haveundergone surgical removal of skin squamous cell or basal cell cancer may beenrolled provided the procedure was completed at least 12 months prior to the dateof provision of informed consent for the study)
Had a complete colonoscopy with adequate bowel preparation in the previous nine (9)years.
Undergoing diagnostic colonoscopy for investigation of symptoms such as unexplainedand long-lasting diarrhea, overt rectal bleeding, e.g., hematochezia or melena,within the previous 30 days. (Blood on toilet paper, after wiping, does notconstitute rectal bleeding)
Undergone colorectal cancer screening within the associated recommended intervals
FOBT/FIT within the previous 12 months
FIT-DNA test within the previous 36 months
Blood-based CRC screening test within the previous 36 months
Computed tomography colonography CTC within the previous 5 years
Flexible sigmoidoscopy within the previous 5 years
Precancerous findings on most recent colonoscopy. This does not include benign,and/or hyperplastic polyps of any size (Note: Tissue biopsies that result in nohistopathology findings are acceptable)
Had a prior colorectal resection for any reason other than sigmoid diverticulardisease
Diagnosis or personal history of any of the following high-risk conditions forcolorectal cancer:
Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) andCrohns disease
Familial adenomatous polyposis (also referred to as FAP, including attenuatedFAP)
Hereditary non-polyposis colorectal cancer syndrome (also referred to as HNPCCor Lynch Syndrome)
Other hereditary cancer syndromes including but are not limited toPeutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardners Syndrome,Turcots (or Crails) Syndrome, Cowdens Syndrome, Juvenile Polyposis,Cronkhite-Canada Syndrome, Neurofibromatosis and Familial HyperplasticPolyposis
Study Design
Study Description
Connect with a study center
Natera
Austin, Texas 78753
United StatesActive - Recruiting
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