Stool Based Markers for the Early Detection of Colorectal Cancer
This study collects stool and blood samples to explore potential markers for early detection of colorectal cancer. Colon cancer is the second most common cancer in men and women. It is a disease that can be treated if it is found early. Colonoscopy is still the best screening tool for colon cancer and the polyps that lead to colon cancer. However, due to a variety of factors, including affordability, time, and age, not all patients are able to be screened. This study aims to determine if stool or blood can be used to detect colon cancers as early or earlier than colonoscopy.
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 2 stool samples to prepare FIT test (x 2) and for adenocarcinoma 4 native specimen vials and 1 slurry
- Nursing women who otherwise meet the eligibility criteria may participate
- Subjects undergoing colonoscopy for screening or surveillance (known prior neoplasms resected)
- No known colorectal neoplastic disease. Undergoing colonoscopic screening based upon current colon cancer screening guidelines
- 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
- Subjects who had colorectal adenocarcinoma that was successfully treated at least three years prior are eligible
- Recent screening colonoscopy (within 1 year of enrollment, with no follow up intervention), poor preparation found at colonoscopy and returning for repeat colonoscopy
- Recent diagnostic colonoscopy (within 1 year of enrollment, with no follow up intervention ) with detection of adenocarcinoma or neoplastic lesion
- Known colorectal adenocarcinoma or neoplastic lesion remains in place after a diagnostic colonoscopy-adenocarcinoma or adenoma in colon at time of blood and stool collection
- Enrolled participants will be grouped into Bins according to one of the following: * Colorectal Cancer-pathologically confirmed colorectal cancer either present at time of stool collection or discovered during colonoscopy (Cancer Bin) * Advanced Adenoma -pathologically confirmed adenoma (Adenoma Bin) ** Sessile serrated adenoma ** Tubulovillous adenoma ** Villous adenoma ** Sessile serrated polyp/adenoma ** Traditional serrated adenoma ** Any adenoma >= 1 cm * Non-advanced adenoma-pathologically confirmed adenoma (Adenoma Bin) * Higher risk no neoplasia (no neoplasia at colonoscopy) ** Negative study colonoscopy and: *** 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 deoxyribonucleic acid (DNA) or for both within 12 months with no follow up intervention * Average risk, no neoplasia (normal colonoscopy) ** 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
Exclusion Criteria
- Cancer patients who have had any surgery, radiation, or chemotherapy for their current colorectal cancer prior to collecting the baseline samples
- 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
- Patient is on active chemotherapy or radiation treatment for any purpose
- Patients with a history of or clinically active inflammatory bowel disease
- Patients with known Hereditary nonpolyposis colorectal cancer syndrome (HNPCC) or familial adenomatous polyposis (FAP)
- Patients with known human immunodeficiency virus (HIV) or chronic active viral hepatitis
- Inability to provide informed consent
- Women who are pregnant
- Computed tomography (CT) colonography (virtual colonoscopy) patients
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00843375.
Locations matching your search criteria
United States
Massachusetts
Boston
Michigan
Ann Arbor
Minnesota
Minneapolis
New York
New York
Oregon
Portland
Texas
Houston
Washington
Seattle
PRIMARY OBJECTIVES:
I. Assessment of the utility of individual stool-based, and serum-based biomarkers for discriminating between patients with adenocarcinomas, patients with adenomas with high grade dysplasia, patients with advanced adenomas defined as adenoma histology of any combination (including sessile serrated adenoma, tubulovillous adenoma, villous adenoma, sessile serrated polyp/adenoma, traditional serrated adenoma OR any adenoma >= 1 cm OR three or more adenomas), patients with adenomas that are not advanced, and colonoscopy with no neoplasia in subjects both at average and higher risk for developing colon cancer.
II. 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:
IIa. Subjects with non-neoplastic endoscopic findings or non-advanced adenomas versus patients with cancers. (Primary)
IIb. Subjects with non-neoplastic endoscopic findings versus patients with cancers. (Secondary)
III. Comparison of the characteristics of individual markers and panels as discriminators to those of the established current standard, fecal immunochemical test (FIT).
IV. 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.
OUTLINE:
Participants scheduled for screening or surveillance colonoscopy undergo collection of stool and blood samples and complete FIT at baseline prior to any colonoscopic preparation procedure. Patients with known unresected, untreated colorectal neoplasm undergo collection of stool and blood samples and complete FIT at baseline before any surgical resection or chemotherapy or radiation therapy is performed. Patients may undergo collection of tissue samples.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationUniversity of Michigan Rogel Cancer Center
Principal InvestigatorDean E Brenner
- Primary IDGLNE 007 / 2018.126
- Secondary IDsNCI-2021-06635, GLNE 007, HUM00029506, HUM00149961, HUM00161344, U01CA086400, UMCC 2005.008, UMCC 2018.126
- ClinicalTrials.gov IDNCT00843375