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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorNatera, Inc.

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Approximately 5,000 participants will enroll in the study in order to obtain 3,000 evaluable participants

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

5,000 Participants
are grouped into 1 trial group
Group A: Participants at average risk for colorectal cancer

Trial outcomes

Primary outcomes

1

Primary Objective

To collect samples for the research use and the development of a blood-based colorectal cancer screening test in the average risk population

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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