NCT06620627

Recruiting

Prospective Collection of Samples to Enable the Development ...

Natera, Inc.Source

Compare

Other study identifiers

Sponsor study identifier

23-073-ECP

Study Type

observational

Estimated enrollment

5,000

Locations

1 country

Sites

1

Timeline

Study Start

January 26, 2024

Actual (reported)

Primary Completion

July 31, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

October 31, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: recruiting
Estimated enrollment: 5,000 participants
Study completion date: October 31, 2025
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 26, 2024
Actual (reported)
First Submitted
September 23, 2024
Actual (reported)
First Posted
October 1, 2024
Actual (reported)
Primary Completion
July 31, 2025
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 31, 2025
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: January 29, 2025
Status Verified: January 2025
Last Update Submitted: January 28, 2025

Conditions

Colorectal Cancer Screening

Keywords

colorectal cancercolon cancer

Outcome Measures

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
12 months

Study Arms (1)

Participants at average risk for colorectal cancer

Participants 40 years of age or older at time of consent, planning or intending to undergo asymptomatic screening colonoscopy.

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

years of age or older at time of consent.

Sponsors & Collaborators

Natera, Inc.
Industrylead

Study Sites (1)

Natera

Austin, Texas, 78753, United States

RECRUITING

Adham Jurdi, MDCONTACT650-489-9050 proceedcrc@natera.com

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples

MeSH Terms

Conditions

Colorectal NeoplasmsColonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Natera PROCEED-CRC Study team

CONTACT

6504899050 proceedcrc@natera.com

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 23, 2024

First Posted

October 1, 2024

Study Start

January 26, 2024

Actual (reported)

Primary Completion

July 31, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

NCT06184594

Evaluating the Efficacy of the eNav Toolkit to Improve Colorectal Cancer Screening

Not ApplicableEnrolling By Invitation

NCT04131946

Cancer Screening; Access; Awareness; Navigation

Not ApplicableCompleted

NCT06241768

Feasibility of a Colorectal Cancer Screening Web App in Primary Care Patients

Not ApplicableCompleted

NCT06757192

CRC Screening in Unscreened Individuals 45-54

Recruiting

NCT04940442

Outreach and Choice in Colorectal Cancer Screening

Not ApplicableUnknown

NCT06401174

Patient Navigation for Colorectal Cancer Screening

Not ApplicableEnrolling By Invitation

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

You may not qualify if:

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)
+1 more criteria

Contact the study team to confirm eligibility.

Study Completion

October 31, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

January 29, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT06620627
Data provider: ClinicalTrials.gov
Source updated: 2025-01-29
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:12 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Participants at average risk for colorectal cancer

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations