Stool-Based Markers for Early Detection of Colon Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if stool or blood tests can detect colon cancer as early as, or earlier than, a colonoscopy (a procedure to examine the colon). Researchers are searching for specific proteins, called biomarkers, in these samples that might indicate colon polyps or cancer. The trial seeks participants who have had colon cancer, polyps, or a family history of colon cancer. Participants will need to provide stool samples and consent to a small blood draw. As a Phase 2 trial, this research measures how well these tests work in an initial, smaller group of people, offering participants a chance to contribute to early detection methods.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this method is safe for detecting colon cancer?
Research has shown that colonoscopy is generally safe. One study found that serious problems, such as bleeding or infections, are rare. Bleeding occurred in about 0.11% of cases, and serious infections in about 0.07%. While these risks are low, awareness is important. Another review found that a tear in the colon can occur, but this is also rare. Overall, trained professionals perform colonoscopies that are well-tolerated.12345
Why are researchers excited about this trial?
Researchers are excited about the evaluation of stool-based markers for colorectal cancer detection because it's a non-invasive method that could potentially identify cancers and adenomas early. Unlike traditional colonoscopies, which require invasive procedures, stool-based tests analyze specific markers in a patient's stool to signal the presence of cancer. This approach is not only more comfortable for patients but also has the potential to increase screening compliance and catch cancers at an earlier, more treatable stage.
What evidence suggests that stool or blood tests could be effective for early detection of colon cancer?
Research has shown that colonoscopy effectively detects colorectal cancer early. Studies have found that colonoscopy can reduce colorectal cancer cases by about 12 per 100,000 people compared to less thorough screening methods. This means it can catch more cases that might otherwise be missed. A colonoscopy uses a camera to examine the colon, allowing doctors to find and remove small growths called polyps before they can become cancerous. Proper bowel preparation, which involves thoroughly cleaning the colon before the test, is crucial for accurate results. Overall, colonoscopy is considered the best tool for early detection of colon cancer.678910
Who Is on the Research Team?
Dean E Brenner, M.D.
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Biospecimen Collection
Collection of stool, blood, serum, plasma, and tissue samples from subjects
Biomarker Analysis
Analysis of individual biomarkers and construction of a panel of markers for future screening trials
Follow-up
Participants are monitored for safety and effectiveness after biospecimen collection
What Are the Treatments Tested in This Trial?
Interventions
- Colonoscopy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan Rogel Cancer Center
Lead Sponsor
Early Detection Research Network
Collaborator
Clinical Genomics Pathology
Industry Sponsor
National Cancer Institute (NCI)
Collaborator
Great Lakes New England Clinical Validation Center
Collaborator
VolitionRx
Collaborator
Department of Health and Human Services
Collaborator
Citations
Our results of lower gastrointestinal endoscopy: evaluation ...
Colonoscopy was successful at the second attempt in 83% (93 patients) of the 112 patients (16%) with insufficient cleaning, after proper bowel preparation. In ...
Quality indicators for colonoscopy
High-quality colonoscopy includes adequate bowel preparation, safe colonoscope insertion to the proximal extent of the colon, detailed ...
Effectiveness of Colonoscopy Screening vs Sigmoidoscopy ...
The additional benefit of colonoscopy screening compared with sigmoidoscopy screening was 12 (95% CI, 10-14) fewer CRC cases per 100 000 person- ...
Early Colonoscopy for Acute Lower GI Bleeding Usually Is ...
Identifying bleeding etiologies by endoscopy affected outcomes in 10,342 cases with hematochezia: CODE BLUE-J Study. Am J Gastroenterol 2021 ...
Follow-up endoscopy rates as an indicator of effectiveness ...
The meta-regression analysis identified complete transit rates and adequate bowel cleansing quality as factors inversely associated with FERs.
Adverse events related to colonoscopy: Global trends and ...
A systematic review study indicated that major complications were reported in 2% of patients with IBD who underwent therapeutic endoscopy[69]. Navaneethan et al ...
ASGE review of adverse events in colonoscopy
Bleeding risk and serious infection rates were .11% and .07%, respectively; however, data included both upper and lower endoscopic procedures.
Complications of colonoscopy
Colonic perforation during colonoscopy may result from mechanical forces against the bowel wall, baro- trauma, or as a direct result of therapeutic procedures.
Complications of colonoscopy: common and rare ...
In this review, we cover common and rarer complications of diagnostic lower gastrointestinal (GI) endoscopy, focusing on how to recognise them, ...
Evaluating the Safety and Quality of Diagnostic ...
This study shows that colonoscopy can be done by general surgeons safely and effectively with adequate training.
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