RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-08-07
Study Completion:2028-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00843375

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Willing to sign informed consent
  2. * Able to physically tolerate removal of up to 60 ml of blood
  3. * Adults at least 18 years old
  4. * Willing to collect 1-2 stool samples and prepare a Fecal Immunochemical Test (FIT)
  5. * Pregnant or nursing women who otherwise meet the eligibility criteria may participate
  6. * Subjects with one of the following:
  7. * Colorectal adenocarcinoma-not treated and in colon at time of stool collection (CRC bin)
  8. * Adenoma-pathologically confirmed adenoma present in colon at time of stool collection (Adenoma Bin)
  9. * Higher Risk Non-neoplastic Bin
  10. * Subjects with a personal history of adenomas (confirmed by pathology) with none present on qualifying colonoscopy
  11. * 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
  12. * Any family history of CRC (1st degree relative)
  13. * Current positive screening stool test for blood, for DNA or for both within 12 months with no follow-up intervention.
  14. * Average Risk, Non-neoplastic Bin
  15. * No history or current finding of any colorectal neoplasia including CRC, adenomas, sessile serrated adenomas and no family history of CRC.
  16. * 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.
  17. * 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.
  18. * Hyperplastic polyps
  19. * Benign mucosal polyps
  20. * Polypoid granulation tissue
  21. * Prolapsed mucosal polyps
  22. * Inflammatory polyp
  23. * Transitional mucosal polyp
  24. * Lipoma
  25. * Gangleoneuroma
  26. * Neuroma
  27. * Hamartomatous polyp
  1. * Cancer patients who have had any surgery, radiation, or chemotherapy for their current colorectal cancer prior to collecting the baseline samples
  2. * History of or clinically active Inflammatory Bowel Disease
  3. * Known HNPCC or FAP
  4. * Inability to provide informed consent.
  5. * Other active malignancy within 3 years of enrollment except any of the following:
  6. * Squamous cell carcinoma of the skin
  7. * Basal cell carcinoma of the skin
  8. * 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)
  9. * Stage Ia Grade 1 adenocarcinoma of the endometrium treated with surgery
  10. * Patients on active chemotherapy or radiation treatment for any purpose
  11. * Known HIV or chronic active viral hepatitis
  12. * Women who are pregnant
  13. * CT colonography (virtual colonoscopy) patients

Contacts and Locations

Study Contact

Cancer AnswerLine
CONTACT
1-800-865-1125
CancerAnswerLine@med.umich.edu

Principal Investigator

Dean E Brenner, M.D.
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
NYU Langone Health
New York, New York, 10016
United States
University of North Carolina
Chapel Hill, North Carolina, 27599
United States
Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
M.D. Anderson Cancer Center
Houston, Texas, 77030
United States
University of Washington
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: University of Michigan Rogel Cancer Center

  • Dean E Brenner, M.D., PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-07
Study Completion Date2028-03

Study Record Updates

Study Start Date2019-08-07
Study Completion Date2028-03

Terms related to this study

Additional Relevant MeSH Terms

  • Colonic Neoplasms