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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The PROCEED-CRC study will prospectively collect blood samples from participants who are at average risk of colorectal cancer (CRC)."
  • "Participants will provide blood samples and will be required to have a colonoscopy performed within 120 days of their blood draw."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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

Study sites (1)

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