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

This study has been completed.
Sponsor:
Collaborators:
Early Detection Research Network
M.D. Anderson Cancer Center
St. Michael's Hospital, Toronto
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Dartmouth-Hitchcock Medical Center
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00843375
First received: February 12, 2009
Last updated: March 15, 2011
Last verified: March 2011
History of Changes
  Purpose

Colonoscopy is the current state-of-the-art screening procedure for detecting colorectal cancers. However, compliance with this screening procedure by the public is very low for a variety of reasons. New screening tools are needed to improve detection of colon cancer. Biomarkers from stool, urine, serum, tissue and plasma may provide valuable initial screening tools to sort the population into those that need colonoscopy and those that most likely do not. This is a cross-sectional study of subjects undergoing clinically-indicated colonoscopy or who have diagnosed colorectal cancer who are willing to provide biospecimens.


Condition
Colonic Neoplasms

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Biospecimen Retention:   Samples With DNA

Tissue (normal colonic mucosa (fixed and frozen) plus adenoma or cancer), plasma, serum, FOBT cards, frozen stool samples, DNA and urine.


Enrollment: 695
Study Start Date: December 2005
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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 Normals
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.

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.
  2. Assessment of the utility of individual stool-based, serum-based and urine-based biomarkers for detecting indicators of carcinogenesis known to be present or not present in adenomas, adenocarcinomas, and normal mucosa.

  3. Construction of a panel of markers from those considered in Objectives 1 and 2 to discriminate, under a number of assumptions concerning prevalence and cost of misclassification, between:

    a Subjects with normal colons versus patients without adenomas, patients with adenomas and patients with cancers; b Subjects with normal colons, patients without adenomas and patients with adenomas, versus subjects with cancers; c Subjects with normal colons versus patients without and patients with adenomas versus patients with cancers.

  4. Comparison of the characteristics of individual markers and panels as discriminators to those of the established current standard, Fecal Occult Blood test (FOBT).
  5. Development of a bank of stool samples linked to serum, tissue, urine 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 meet our goals the investigators propose to collect stool, rectal mucus, serum, plasma, and urine samples from 800 subjects (200 colorectal cancers, 200 adenomas, 200 higher risk normals and 200 normal colons for controls). The stool samples will be assayed for stool-based biomarkers. EDRN Common Data Elements (CDEs) will be completed by the recruiting sites and provided for the laboratories developing the assay.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects undergoing clinically-indicated colonoscopy. Recruitment is from the endoscopy schedules for collaborating locations.

Criteria

Inclusion Criteria:

  • Willing to sign informed consent
  • Able to physically tolerate removal of up to 58 ml of blood at one to two different time points
  • Adults at least 18 years old
  • Willing to collect 1-2 stool samples and prepare a FOBT card and five specimen vials from each stool sample
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00843375

Locations
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
University of Michigan
Early Detection Research Network
M.D. Anderson Cancer Center
St. Michael's Hospital, Toronto
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Dean E Brenner, MD University of Michigan
  More Information

No publications provided

Responsible Party: Dr. Dean Brenner, MD, Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT00843375     History of Changes
Other Study ID Numbers: GLNE 007, 5U01CA086400-08
Study First Received: February 12, 2009
Last Updated: March 15, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adenoma
Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 16, 2013