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

Last updated: January 28, 2025
Sponsor: Natera, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colon Cancer Screening

Treatment

N/A

Clinical Study ID

NCT06620627
23-073-ECP
  • Ages > 40
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 colonoscopyprocedure.

  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

Exclusion Criteria:

  1. Any prior history of any kind of malignancy (exception: participants who haveundergone surgical removal of skin squamous cell or basal cell cancer may beenrolled provided the procedure was completed at least 12 months prior to the dateof 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 unexplainedand long-lasting diarrhea, overt rectal bleeding, e.g., hematochezia or melena,within the previous 30 days. (Blood on toilet paper, after wiping, does notconstitute rectal bleeding)

  4. Undergone colorectal cancer screening within the associated recommended intervals

  5. FOBT/FIT within the previous 12 months

  6. FIT-DNA test within the previous 36 months

  7. Blood-based CRC screening test within the previous 36 months

  8. Computed tomography colonography CTC within the previous 5 years

  9. Flexible sigmoidoscopy within the previous 5 years

  10. Precancerous findings on most recent colonoscopy. This does not include benign,and/or hyperplastic polyps of any size (Note: Tissue biopsies that result in nohistopathology findings are acceptable)

  11. Had a prior colorectal resection for any reason other than sigmoid diverticulardisease

  12. Diagnosis or personal history of any of the following high-risk conditions forcolorectal cancer:

  13. Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) andCrohns disease

  14. Familial adenomatous polyposis (also referred to as FAP, including attenuatedFAP)

  15. Hereditary non-polyposis colorectal cancer syndrome (also referred to as HNPCCor Lynch Syndrome)

  16. Other hereditary cancer syndromes including but are not limited toPeutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardners Syndrome,Turcots (or Crails) Syndrome, Cowdens Syndrome, Juvenile Polyposis,Cronkhite-Canada Syndrome, Neurofibromatosis and Familial HyperplasticPolyposis

Study Design

Total Participants: 5000
Study Start date:
January 26, 2024
Estimated Completion Date:
October 31, 2025

Study Description

Participants who meet study inclusion criteria will be invited to enroll in the study and will provide written consent prior to study procedures. Participants will provide blood samples and will be required to have a colonoscopy performed within 120 days of their blood draw. No test results from the blood collection will be provided to participants or clinicians.

Connect with a study center

  • Natera

    Austin, Texas 78753
    United States

    Active - Recruiting

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