Status:
RECRUITING
Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
Lead Sponsor:
University of Michigan Rogel Cancer Center
Collaborating Sponsors:
Early Detection Research Network
Clinical Genomics Pathology
Conditions:
Colonic Neoplasms
Eligibility:
All Genders
18+ years
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 7 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00843375
Start Date
August 7 2019
End Date
March 1 2028
Last Update
May 8 2025
Active Locations (13)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Carle Cancer Center
Urbana, Illinois, United States, 61801
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
4
University of Michigan
Ann Arbor, Michigan, United States, 48109