Collecting blood samples to develop a colorectal cancer screening test

Prospective Collection of Samples to Enable the Development of Natera Screening Assay for Early Cancer Detection (PROCEED-CRC)

This study is collecting blood samples from people at average risk for colorectal cancer to see if they can create a new blood test for early detection of the disease.

Quick facts

• Study type: Observational
• Enrollment: 5000 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Natera, Inc. (industry)
• Locations: 1 site (Austin, Texas)
• Trial ID: NCT06620627 on ClinicalTrials.gov

What this trial studies

The PROCEED-CRC study aims to collect blood samples from participants who are at average risk for colorectal cancer. Participants will provide written consent and undergo blood draws, followed by a colonoscopy within 120 days. The collected samples will be utilized for research purposes to develop a blood-based screening assay for early detection of colorectal cancer. Participants will not receive any test results from the blood collection.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40 years or older who are planning to undergo asymptomatic screening colonoscopy.

Not a fit: Patients with a prior history of malignancy or those undergoing diagnostic colonoscopy for symptoms will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a non-invasive blood test for early detection of colorectal cancer, improving screening rates and outcomes.

How similar studies have performed: While there have been various approaches to cancer screening, the specific development of a blood-based assay for colorectal cancer detection is still largely novel.

Eligibility criteria

Inclusion Criteria:

1. 40 years of age or older at time of consent.
2. Planning or intending to undergo asymptomatic screening colonoscopy.
3. Able to tolerate venipuncture for research draw(s).
4. Able and willing to provide blood samples within the 120 days prior to a colonoscopy procedure.
5. Willing and able to comply with the study visit schedule and study requirements.
6. Signed informed consent(s) must be obtained prior to participation in the study

Exclusion Criteria:

1. Any prior history of any kind of malignancy (exception: participants who have undergone surgical removal of skin squamous cell or basal cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study)
2. Had a complete colonoscopy with adequate bowel preparation in the previous nine (9) years.
3. Undergoing diagnostic colonoscopy for investigation of symptoms such as unexplained and long-lasting diarrhea, overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding)
4. Undergone colorectal cancer screening within the associated recommended intervals

   1. FOBT/FIT within the previous 12 months
   2. FIT-DNA test within the previous 36 months
   3. Blood-based CRC screening test within the previous 36 months
   4. Computed tomography colonography CTC within the previous 5 years
   5. Flexible sigmoidoscopy within the previous 5 years
5. Precancerous findings on most recent colonoscopy. This does not include benign, and/or hyperplastic polyps of any size (Note: Tissue biopsies that result in no histopathology findings are acceptable)
6. Had a prior colorectal resection for any reason other than sigmoid diverticular disease
7. Diagnosis or personal history of any of the following high-risk conditions for colorectal cancer:

   1. Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohns disease
   2. Familial adenomatous polyposis (also referred to as FAP, including attenuated FAP)
   3. Hereditary non-polyposis colorectal cancer syndrome (also referred to as HNPCC or Lynch Syndrome)
   4. Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardners Syndrome, Turcots (or Crails) Syndrome, Cowdens Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis

Where this trial is running

Austin, Texas

• Natera — Austin, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Natera PROCEED-CRC Study team

Conditions: Colorectal Cancer Screening, colorectal cancer, colon cancer