Study Name:
Specimen Collection from Participants Due for Colorectal Cancer Screening, Surveillance, or Treatment: IMPACT

Description:
An observational research study to collect de-identified, clinically characterized specimens for use in developing and evaluating the performance of new biomarker assays and devices for detection of CRC. The goal of the IMPACT study is to develop new colorectal cancer screening tests, and make continued improvements to their current screening portfolio, to detect advanced adenomas and colorectal cancer even in its most effectively treatable stages.

 Eligibility:
The study will enroll approximately 25,000 participants across the United States in three cohorts.

 Cohort 1 - CRC Screening Population

• Participant is at least age 40 years.

• Participant is due for a screening colonoscopy, or a follow-up colonoscopy for a positive non-invasive CRC screening test, per standard-of-care within 180 days of enrollment.

Cohort 2 - Advanced Neoplasia Population

• Participant is at least age 18 years.

• Participant has a diagnosis of CRC (any stage) confirmed with a tissue biopsy, or has a colorectal lesion estimated to be at least 10 mm in size suspicious for CRC or APL on a pre-enrollment colonoscopy, sigmoidoscopy, or computed tomography (CT) colonography.

• At the time of enrollment, the residual lesion in the colon is estimated to be at least 10 mm in size as to require additional therapeutic intervention.

Cohort 3 - Increased Risk/Surveillance Population

• Participant is at least age 18 years.

• Participant is due for a surveillance colonoscopy per healthcare provider’s advice within 60 days of enrollment.

• Participant has at least one of the following:

• Diagnosis of a relevant familial (hereditary) cancer syndrome or other polyposissyndrome, such as Familial adenomatous polyposis (FAP or Gardner’s), Hereditary nonpolyposis colorectal cancer syndrome (HNPCC or Lynch), Peutz-Jeghers, MYH-Associated Polyposis (MAP), Turcot’s (or Crail’s), Cowden’s, Juvenile Polyposis, Cronkhite-Canada, Neurofibromatosis, or Serrated Polyposis,

• Diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn’s disease,

• At least one first-degree relative diagnosed with CRC, Personal history of colorectal lesions requiring a repeat colonoscopy ≤6 years following their most recent colonoscopy.

• Has experienced overt rectal bleeding (e.g., hematochezia, melena) within the previous 30 days.

Participation:

Participation is simple, but will vary slightly depending on eligibility cohort.

If participants have had a recent diagnosis of colorectal cancer, they will need to provide a self-collected stool sample as well as a simple blood draw, (we will arrange for this to be done in the convenience and privacy of their own home), at least 7 days after the coloscopy, but before any treatment for their colorectal cancer or advanced adenoma diagnosis begins (ie. surgery, chemotherapy).

If participants have a recent diagnosis of advanced neoplasm or are scheduled for routine colonoscopy, they will need to provide a self-collected stool sample as well as a blood draw, (we will arrange for this to be done in the convenience and privacy of their own home), before any bowel prep begins.

Participants may also be asked to complete a questionnaire about their experience with the blood and/or stool collections.

Test Result Reporting:

This is an observational specimen collection study: no results will be reported to the Investigator or participant.