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Prospective Collection of Samples to Enable the Development of Natera Screening Assay for Early Cancer Detection | Clinical Trials | Clareo Health

RECRUITING

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)

NCT06620627•Natera, Inc.

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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 more criteria

Locations (1)

Natera

Austin, Texas, United States

Key Dates

Start Date

January 26, 2024

Primary Completion Date

July 31, 2025

Completion Date

October 31, 2025

Last Updated

January 29, 2025

Enrollment

5,000

ESTIMATED participants

Conditions

Colorectal Cancer Screening

Contacts

Natera PROCEED-CRC Study team

CONTACT

6504899050 proceedcrc@natera.com

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ENROLLING_BY_INVITATIONNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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