NCT06620627 · Natera, Inc.
Prospective Collection of Samples to Enable the Development of Natera Screening Assay for Early Cancer Detection
(PROCEED-CRC)
What this study is about
The PROCEED-CRC study will prospectively collect blood samples from participants who are at average risk of colorectal cancer (CRC). Samples will be used for research use and the development of a blood-based CRC screening test.
View original scientific description
The PROCEED-CRC study will prospectively collect blood samples from participants who are at average risk of colorectal cancer (CRC). Samples will be used for research use and the development of a blood-based CRC screening test.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 colonoscopy procedure.
- 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 criteria
- 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)
- Had a complete colonoscopy with adequate bowel preparation in the previous nine (9) years.
- 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)
- 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 no histopathology findings are acceptable)
- Had a prior colorectal resection for any reason other than sigmoid diverticular disease
- Diagnosis or personal history of any of the following high-risk conditions for colorectal cancer:
- Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohns disease
- Familial adenomatous polyposis (also referred to as FAP, including attenuated FAP)
- Hereditary non-polyposis colorectal cancer syndrome (also referred to as HNPCC or Lynch Syndrome)
- 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
- Austin, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 29, 2025 · Source of record for eligibility and locations