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Testing Stool and Blood Markers for Early Detection of Colon Cancer

Studies stool and blood markers as possible early tests for colon cancer and polyps.

Key facts

Who runs it
University of Michigan Rogel Cancer Center
Where
Toronto, CanadaSee the siteAlso in 2 other countries, 12 sites
Trial code
Registry title
Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
Status
Recruiting
People taking part
1,200 people, planned
Started
7 Aug 2019
Expected to end
Mar 2028
Type of study
Observational, 4 groups
Record updated
11 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who have untreated colorectal cancer, an adenoma (a type of colon polyp), or who are at higher or average risk of colon cancer. They give blood and stool samples.

Age
At least 18 years old.
Sex
All sexes can join.
Disease stage
Untreated colorectal adenocarcinoma in the colon, or an adenoma confirmed by pathology in the colon. People with no tumours who are at higher or average risk of colon cancer can also join.
Earlier treatment
People with colorectal cancer cannot have had surgery, radiation or chemotherapy for it before the first samples are taken.

Main reasons for not taking part

  • Inflammatory bowel disease, past or active
  • Known HNPCC or FAP
  • Other active cancer within 3 years, with a few skin and cervical or womb exceptions
  • Active chemotherapy or radiation for any reason
  • Known HIV or chronic active viral hepatitis

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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; Subjects with a personal history of CRC (longer than 3 years ago because of exclusion criteria of cancer within last 3 years) with none present at time of qualifying colonoscopy; 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

Who cannot take part

  • Cancer patients who have had any surgery, radiation, or chemotherapy for their current colorectal cancer prior to collecting the baseline samples
  • 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
  • History of or clinically active Inflammatory Bowel Disease
  • Known HIV or chronic active viral hepatitis
  • Known HNPCC or FAP
  • Inability to provide informed consent
  • Women who are pregnant
  • CT colonography (virtual colonoscopy) patients

Where in Canada

Also in 2 other countries, 12 sites

  • St. Michael's HospitalToronto, CanadaContact: Cancer AnswerLineNo longer taking part

About the trial

What the trial wants to find out

Colon cancer is the second most common cancer in men and women. It is a disease that can be prevented if it is found early. Colonoscopy is still the best screening tool for colon cancer and the polyps that turn into colon cancer. However, due to a variety of factors, including affordability, time, and age, not all patients are able to be screened. Researchers are working on other options for early detection that are as accurate as colonoscopy.

Read full original descriptionShow less

The purpose of this study if to determine if stool or blood can be used to detect colon cancers as early or earlier than colonoscopy. The researchers plan to use these samples to learn about specific proteins (also known as biomarkers) that may indicate colon polyps, colon cancer or an increased risk of developing colon cancer. In order to learn more about preventing and detecting colon and rectal cancer, we are collecting samples from subjects with cancer, adenomas, and colonoscopies who may be at risk for polyps.

The 4 groups in the trial

  • Higher risk, no neoplasia

    Negative study colonoscopy and one or more of the following: * Subjects with a personal history of adenomas (confirmed by pathology) with none present on qualifying colonoscopy * Subjects with a personal history of colorectal cancer (CRC) (longer than 3 years ago because of exclusion criteria of cancer within last 3 years) with none present at time of qualifying colonoscopy * 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

  • Adenoma

    Pathologically confirmed adenomas, both non-advanced adenoma and advanced. Advanced adenoma includes any of the following: * Sessile serrated adenoma * Tubulovillous adenoma * Villous adenoma * Sessile serrated polyp/adenoma * Traditional serrated adenoma * Any adenoma ≥1 cm

  • Colorectal adenocarcinoma

    Pathologically confirmed colorectal cancer either present at time of stool collection or discovered during colonoscopy

  • Average risk, no neoplasia

    No neoplasia found at colonoscopy and: * No prior history of adenomas or sessile serrated adenomas * No prior history of CRC * No first degree family history of CRC * Negative colorectal cancer screening test (if performed) for blood, for DNA or for both within 12 months.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
Plain-language title
Testing Stool and Blood Markers for Early Detection of Colon CancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
11 May 2026