No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 and older
Sex
Any
Study type
Observational
Participants needed
5,000 (estimated)
Sponsor
Natera, Inc. · Industry
Who this trial is looking for
This trial is looking for people aged 40 and older who are planning to have a screening colonoscopy. Participants will provide blood samples to help develop a new blood test for colorectal cancer detection.
Are You a Good Fit for This Trial?
You may be able to join if
I am 40 years of age or older.
I plan to have a screening colonoscopy.
I can tolerate having my blood drawn.
I can provide blood samples within 120 days before my colonoscopy.
I am willing to follow the study requirements.
You may not be able to join if
I have had any type of cancer before.
I had a complete colonoscopy in the last 9 years.
I had a diagnostic colonoscopy for symptoms within the last 30 days.
I had a colorectal cancer screening in the past 12 months.
I had precancerous findings in my last colonoscopy.
I had a colorectal surgery for any reason other than diverticular disease.
I have inflammatory bowel disease.
I have a family history of hereditary cancer syndromes.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
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Status
Eligibility Criteria
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. Wi…
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. 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
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