Prospective Collection of Samples to Enable the Development of Natera Screening Assay for Early Cancer Detection

Launched by NATERA, INC. · Sep 27, 2024

Keywords

ClinConnect Summary

The PROCEED-CRC study is looking to develop a new blood test that can help detect colorectal cancer (CRC) early. This trial will collect blood samples from people who are at average risk for CRC and who are planning to have a routine colonoscopy, which is a procedure to check the colon for any signs of cancer. The goal is to see if these blood samples can be used to create a reliable screening test for CRC.

To participate in this study, you need to be at least 40 years old and planning to undergo a colonoscopy without any current symptoms. You should also be able to provide blood samples within 120 days before your procedure. However, if you have had certain types of cancer in the past, underwent a colonoscopy in the last nine years, or have specific high-risk conditions, you may not be eligible. If you join the study, you'll help researchers in their efforts to improve early cancer detection methods, and you'll be closely monitored throughout the process.

Gender

ALL

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