Recruiting

Stool Based Markers

Sponsor:

University of Michigan Rogel Cancer Center

Code:

NCT00843375

Conditions

Colonic Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

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.

Conditions

Colonic Neoplasms

Study ID

NCT00843375

Start date

Aug 7, 2019

Status verified date

May, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

1200 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Biospecimen Retention: Samples with DNA [ Time Frame: At 1 day of biospecimen collection ]

Central Contacts and Locations

Central contacts

Cancer AnswerLine

1-800-865-1125CancerAnswerLine@med.umich.edu

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Karen Zaghiyan

310-289-9224Karen.Zaghiyan@cshs.org

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Principal Investigator:

Sapna Syngal, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Cancer AnswerLine

800-865-1125CancerAnswerLine@med.umich.edu

Principal Investigator:

Elena Stoffel, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Principal Investigator:

Tim Church, MD

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Aasma Shaukatr, MD

212-686-2500Shaukat@nyulangone.org

Jessica Rauch

646-501-9624

Principal Investigator:

Aasma Shaukat, MD

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Seth Crockett

919-962-2608crockese@ohsu.edu

M.D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Robert Bresalier, MD

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Principal Investigator:

William Grady, MD

More Information

Sponsor

University of Michigan Rogel Cancer Center

Last update posted

May 11, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Michigan Rogel Cancer Center on 2026-05-11.