RECRUITING

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

Conditions

Colorectal Cancer Screening colorectal cancer colon cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-26

Study Completion:2025-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06620627

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Natera PROCEED-CRC Study team

CONTACT

6504899050

proceedcrc@natera.com

Study Locations (Sites)

Natera

Austin, Texas, 78753

United States

Collaborators and Investigators

Sponsor: Natera, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-26

Study Completion Date2025-06-30

Study Record Updates

Study Start Date2024-01-26

Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

colorectal cancer
colon cancer

Additional Relevant MeSH Terms

Colorectal Cancer Screening