Stool-Based Markers for Early Detection of Colon Cancer

Recruiting at 8 trial locations

Overseen By Cancer AnswerLine

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan Rogel Cancer Center

Must not be taking: Chemotherapy, Radiation

Disqualifiers: Inflammatory bowel disease, HNPCC, FAP, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

1200 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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

Willing to sign informed consent

Able to physically tolerate removal of up to 60 ml of blood

Willing to collect 1-2 stool samples and prepare a Fecal Immunochemical Test (FIT)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biospecimen Collection

Collection of stool, blood, serum, plasma, and tissue samples from subjects

1 day

1 visit (in-person)

Biomarker Analysis

Analysis of individual biomarkers and construction of a panel of markers for future screening trials

Ongoing

Follow-up

Participants are monitored for safety and effectiveness after biospecimen collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Colonoscopy

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

Early Detection Research Network

Collaborator

Trials

4

Recruited

17,500+

Clinical Genomics Pathology

Industry Sponsor

Trials

3

Recruited

1,800+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Great Lakes New England Clinical Validation Center

Collaborator

Trials

1

Recruited

1,200+

VolitionRx

Collaborator

Trials

1

Recruited

1,200+

Department of Health and Human Services

Collaborator

Trials

240

Recruited

944,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4379822/

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 ...

2. giejournal.org giejournal.org/article/S0016-5107(24)03164-X/fulltext

Quality indicators for colonoscopy High-quality colonoscopy includes adequate bowel preparation, safe colonoscope insertion to the proximal extent of the colon, detailed ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2815644

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- ...

4. gi.org gi.org/journals-publications/ebgi/kumar_feb2023/

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 ...

5. bmjopengastro.bmj.com bmjopengastro.bmj.com/content/12/1/e001800

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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6337013/

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 ...

7. giejournal.org giejournal.org/article/S0016-5107(19)32115-7/fulltext

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.

8. asge.org asge.org/docs/default-source/education/practice_guidelines/doc-56321364-c4d8-4742-8158-55b6bef2a568.pdf

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.

9. bmjopengastro.bmj.com bmjopengastro.bmj.com/content/10/1/e001193

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, ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10259754/

Evaluating the Safety and Quality of Diagnostic ... This study shows that colonoscopy can be done by general surgeons safely and effectively with adequate training.