Colonic NeoplasmsNCT00843375
Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
An observational study of Colonic Neoplasms, run by University of Michigan Rogel Cancer Center at 13 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Neoplasms
- How many people
- 1,200 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 7 Aug 2019to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with colorectal cancer and adenomas and scheduled for surgical or endoscopic resection or subjects scheduled for a colonoscopy will be recruited from collaborating consortium centers.
Who may be able to join
- 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:
Show all 27Show fewer
- 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 join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
13 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 3 countries
United States11 sites, 8 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Cancer AnswerLine, 800-865-1125, CancerAnswerLine@med.umich.edu
Elena Stoffel, MD
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Sapna Syngal, MD
- Completed
University of North Carolina
Chapel Hill, North Carolina, 27599
- Completed
Hershey Medical Center
Hershey, Pennsylvania, 17033
- Recruiting
M.D. Anderson Cancer Center
Houston, Texas, 77030
Robert Bresalier, MD
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Karen Zaghiyan, 310-289-9224, Karen.Zaghiyan@cshs.org
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Tim Church, MD
- Recruiting
NYU Langone Health
New York, New York, 10016
Aasma Shaukatr, MD, 212-686-2500, Shaukat@nyulangone.org
Jessica Rauch, 646-501-9624
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Seth Crockett, 919-962-2608, crockese@ohsu.edu
- Recruiting
University of Washington
Seattle, Washington, 98195
William Grady, MD
- Completed
Carle Cancer Center
Urbana, Illinois, 61801
Australia1 site, 1 recruiting
- Recruiting
Flinders Medical Center
Adelaide, South Australia, 5001
Graeme Young, MD, MBBS
About this study
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.
Read the detailed description
In recognition of the fact that novel potential biomarkers are continually being identified and will need to be validated in a rapid, efficient and scientifically rigorous manner, the NCI has made an enormous commitment to the development of a network that will facilitate biomarker development and validation in multiple organ sites. As part of the National Cancer Institute-funded Early Detection Research Network (EDRN), the Great Lakes-New England Clinical Epidemiological Center (GLNE CEC) proposes a research study that validates potential molecular markers ("biomarkers") for the detection of precancerous and cancerous conditions and cancer risk assessment. Although examples of such biomarkers are currently in clinical use (i.e. CEA, CA-125), there are limitations to all of them. Our consortium focuses on gastrointestinal neoplasia. The goals of this phase of the proposed research are:
- Assessment of the utility of individual stool-based, serum-based and urine-based biomarkers for discriminating between patients with adenocarcinomas, patients with adenomas, patients without adenomas and normal subjects both at normal and high risk for developing colon cancer.
- Construction of a panel of markers from those considered in Objective 1 to discriminate, under a number of assumptions concerning prevalence and cost of misclassification, between:
- Subjects with normal colons versus patients without adenomas, patients with adenomas and patients with cancers;
- Subjects with normal colons, patients without adenomas and patients with adenomas, versus subjects with cancers;
- Subjects with normal colons versus patients without and patients with adenomas versus patients with cancers.
- Comparison of the characteristics of individual markers and panels as discriminators to those of the established current standard, fecal immunochemical test (FIT).
- Continued support of a renewal of a bank of stool samples linked to serum, tissue, and clinical data from patients with colorectal cancer, adenomas and normal controls for validation of stool-based markers that may be developed in the future.
To build our collection, we propose to collect stool, FIT, serum, plasma, and tissue samples from 1200 new subjects. Each biomarker will be analyzed individually and considered as a potential panel marker to be used for future largescale screening longitudinal trials. (This protocol previously recruited an additional 682 subjects from January 2006 to June 2010.)
- Conditions
- Colonic Neoplasms
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biospecimen Retention: Samples with DNA
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.
Measured: At 1 day of biospecimen collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study start7 Aug 2019
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Early Detection Research Network, Clinical Genomics Pathology, VolitionRx, Department of Health and Human Services, Great Lakes New England Clinical Validation Center, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Dean E Brenner, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843375
- Sponsor's protocol ID
- UMCC 2018.126 GLNE 007
- Other IDs
- U01CA086400, HUM00149961, UMCC 2018.126, HUM00029506, UMCC 2005.008, HUM00161344
- Status last verified
- May 2026
- First submitted
- 12 Feb 2009
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
- ClinicalTrials.gov ID
- NCT00843375
- Acronym / sponsor ID
- UMCC 2018.126 GLNE 007
- Conditions
- Colonic Neoplasms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Early Detection Research Network, Clinical Genomics Pathology, VolitionRx, Department of Health and Human Services, Great Lakes New England Clinical Validation Center, National Cancer Institute (NCI)
- Study start
- 7 Aug 2019 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 13 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In recognition of the fact that novel potential biomarkers are continually being identified and will need to be validated in a rapid, efficient and scientifically rigorous manner, the NCI has made an enormous commitment to the development of a network that will facilitate biomarker development and validation in multiple organ sites. As part of the National Cancer Institute-funded Early Detection Research Network (EDRN), the Great Lakes-New England Clinical Epidemiological Center (GLNE CEC) proposes a research study that validates potential molecular markers ("biomarkers") for the detection of precancerous and cancerous conditions and cancer risk assessment. Although examples of such biomarkers are currently in clinical use (i.e. CEA, CA-125), there are limitations to all of them. Our consortium focuses on gastrointestinal neoplasia. The goals of this phase of the proposed research are:
- Assessment of the utility of individual stool-based, serum-based and urine-based biomarkers for discriminating between patients with adenocarcinomas, patients with adenomas, patients without adenomas and normal subjects both at normal and high risk for developing colon cancer.
- Construction of a panel of markers from those considered in Objective 1 to discriminate, under a number of assumptions concerning prevalence and cost of misclassification, between:
- Subjects with normal colons versus patients without adenomas, patients with adenomas and patients with cancers;
- Subjects with normal colons, patients without adenomas and patients with adenomas, versus subjects with cancers;
- Subjects with normal colons versus patients without and patients with adenomas versus patients with cancers.
- Comparison of the characteristics of individual markers and panels as discriminators to those of the established current standard, fecal immunochemical test (FIT).
- Continued support of a renewal of a bank of stool samples linked to serum, tissue, and clinical data from patients with colorectal cancer, adenomas and normal controls for validation of stool-based markers that may be developed in the future.
To build our collection, we propose to collect stool, FIT, serum, plasma, and tissue samples from 1200 new subjects. Each biomarker will be analyzed individually and considered as a potential panel marker to be used for future largescale screening longitudinal trials. (This protocol previously recruited an additional 682 subjects from January 2006 to June 2010.)
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with colorectal cancer and adenomas and scheduled for surgical or endoscopic resection or subjects scheduled for a colonoscopy will be recruited from collaborating consortium centers.
Key inclusion criteria (27 listed)
- 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
Key exclusion criteria (13 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biospecimen Retention: Samples with DNA
Time frame: At 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dean E Brenner, M.D. principal investigator
University of Michigan
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Neoplasms, run by University of Michigan Rogel Cancer Center at 13 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer AnswerLine (1-800-865-1125, CancerAnswerLine@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biospecimen Retention: Samples with DNA (time frame: At 1 day of biospecimen collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.