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Evaluating Stool and Blood for Early Colon Cancer Detection

This observational study is looking for better ways to find colon cancer and polyps (growths that can turn into cancer) early. Currently, colonoscopy is the best screening tool, but researchers want to find other options that are just as accurate. This study aims to see if analyzing stool or blood samples can detect colon cancers and polyps as early as, or even earlier than, a colonoscopy. Researchers will use these samples to identify specific proteins (biomarkers) that might indicate the presence of polyps, colon cancer, or an increased risk of developing it. You may be eligible if you are at least 18 years old, willing to provide blood and stool samples, and meet other criteria related to your colon health.

Study design
This is an observational study aiming to enroll 1200 participants. It is not testing a specific drug or intervention, but rather observing and collecting samples.
What's involved
You would need to sign an informed consent, be able to give up to 60 ml of blood, and collect 1-2 stool samples, preparing a Fecal Immunochemical Test (FIT).
Compensation
Not stated in the trial record.
Follow-up
Biospecimen retention (samples with DNA) will be measured at 1 day of biospecimen collection. Further follow-up is not specified.

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NCT00843375

Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas

Recruiting
Not specifiedAges 18+Observational
University of Michigan Rogel Cancer Center
~1,200 participants
Updated 2026-05-11 on ClinicalTrials.gov

At a glance

Recruiting sites
9 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Biospecimen Retention: Samples with DNA
Measured over At 1 day of biospecimen collection

Conditions

Colonic Neoplasms

Explore related trials

AdenomaColon NeoplasmColorectal Carcinoma

Where it's being run

13 sites across 13 states
California1
Illinois1
Massachusetts1
Michigan1
Minnesota1
New York1
North Carolina1
Oregon1

Study leadership

  • Dean E Brenner, M.D. · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Cancer AnswerLine
[email protected]
1-800-865-1125
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Willing to sign informed consent
Able to physically tolerate removal of up to 60 ml of blood
Adults at least 18 years old
Willing to collect 1-2 stool samples and prepare a Fecal Immunochemical Test (FIT)
Pregnant or nursing women who otherwise meet the eligibility criteria may participate
Subjects with one of the following:
Colorectal adenocarcinoma-not treated and in colon at time of stool collection (CRC bin)
Adenoma-pathologically confirmed adenoma present in colon at time of stool collection (Adenoma Bin)
Higher Risk Non-neoplastic Bin
Subjects with a personal history of adenomas (confirmed by pathology) with none present on qualifying colonoscopy

Exclusion

Any family history of CRC (1st degree relative)
Current positive screening stool test for blood, for DNA or for both within 12 months with no follow-up intervention.
Average Risk, Non-neoplastic Bin
No history or current finding of any colorectal neoplasia including CRC, adenomas, sessile serrated adenomas and no family history of CRC.
Subjects who had CRC that was successfully treated at least three years ago may be considered eligible for the adenoma bin if their polyps are adenomas and there is no evidence of CRC, or for the higher risk non-neoplastic bin as noted above.
Subjects whose screening colonoscopy shows any of these types of polyps may be included in the non-neoplastic or the higher risk non-neoplastic bin if they meet the other criteria noted above.
Hyperplastic polyps
Benign mucosal polyps
Polypoid granulation tissue
Prolapsed mucosal polyps
Inflammatory polyp
Transitional mucosal polyp
Lipoma
Gangleoneuroma
Neuroma
Hamartomatous polyp
Cancer patients who have had any surgery, radiation, or chemotherapy for their current colorectal cancer prior to collecting the baseline samples
History of or clinically active Inflammatory Bowel Disease
Known HNPCC or FAP
Inability to provide informed consent.
Other active malignancy within 3 years of enrollment except any of the following:
Squamous cell carcinoma of the skin
Basal cell carcinoma of the skin
Carcinoma in situ of the cervix, Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery only. (Excluded if had pelvic radiation)
Stage Ia Grade 1 adenocarcinoma of the endometrium treated with surgery
Patients on active chemotherapy or radiation treatment for any purpose
Known HIV or chronic active viral hepatitis
Women who are pregnant
CT colonography (virtual colonoscopy) patients

What this trial measures

  • Biospecimen Retention: Samples with DNAAt 1 day of biospecimen collection

    Blood samples, up to 60 mls, will be obtained according to standard operating procedures. Subjects will collect stool samples per the schedule in the study calendar. Collection of Frozen Normal and Adenoma or Cancer Tissue: For individuals with large adenomas who are undergoing endoscopic resection, the fresh surgical sample will be obtained by the endoscopist.