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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00843375
Recruitment Status : Recruiting
First Posted : February 13, 2009
Last Update Posted : January 27, 2020
Sponsor:
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)
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

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.


Condition or disease
Colonic Neoplasms

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:

  1. 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.
  2. 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:

    1. Subjects with normal colons versus patients without adenomas, patients with adenomas and patients with cancers;
    2. Subjects with normal colons, patients without adenomas and patients with adenomas, versus subjects with cancers;
    3. Subjects with normal colons versus patients without and patients with adenomas versus patients with cancers.
  3. Comparison of the characteristics of individual markers and panels as discriminators to those of the established current standard, fecal immunochemical test (FIT).
  4. 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 1000 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 had previously recruited subjects from January 2006 to June 2010.)

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Study Type : Observational
Estimated Enrollment : 1800 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
Actual Study Start Date : August 7, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Group/Cohort
Normal
Subjects who have had a colonoscopy and no adenomas or cancer was found.
Adenomas
Subjects who had an adenoma found on colonoscopy. All samples must be collected before the adenoma is removed.
Colorectal Adenocarcinoma
Subjects who have confirmed colorectal carcinoma. All samples must be collected before the cancer is removed.
High Risk Normal
Subjects who had a colonoscopy without adenomas or cancer AND have a history of adenomas, colorectal cancer (greater than 3 years ago) or a family history of cancer or adenomas.



Primary Outcome Measures :
  1. 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.


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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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 Normal 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)
    • Normal Control Bin

      • No history or current finding of any colon neoplasia including CRC, adenomas, no personal or family history of HNPCC or FAP
      • 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 normal bin as noted above.
      • Subjects whose screening colonoscopy shows any of these types of polyps may be included in the normal or the higher risk normal 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
  • Patients with a history of or clinically active Inflammatory Bowel Disease
  • Patients with 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
  • Subjects with known HIV or chronic viral hepatitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843375


Contacts
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Contact: Kirk D Herman, B.S. 734-615-2922 kherman@med.unich.edu

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Sapna Syngal, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Kirk D Herman, BS    734-615-2922    kherman@med.unich.edu   
Principal Investigator: Dean Brenner, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Principal Investigator: Tim Church, MD         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Principal Investigator: John Barron, MD         
United States, Pennsylvania
Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Principal Investigator: Mack Ruffin, MD         
United States, Texas
M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Robert Bresalier, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Principal Investigator: William Grady, MD         
Canada, Ontario
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada
Principal Investigator: Norman Marcon, MD         
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
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)
Investigators
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Principal Investigator: Dean E Brenner, M.D. University of Michigan
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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT00843375    
Other Study ID Numbers: GLNE 007
5U01CA086400-08 ( U.S. NIH Grant/Contract )
HUM00149961 ( Other Identifier: University of Michigan )
UMCC 2018.126 ( Other Identifier: University of Michigan )
HUM00029506 ( Other Identifier: University of Michigan )
UMCC 2005.008 ( Other Identifier: University of Michigan )
First Posted: February 13, 2009    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenoma
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type