RecruitingOBSERVATIONAL

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

Bowel cancer is a common cancer, but if found early, it can often be treated successfully. While a colonoscopy is the best way to check for bowel cancer and the growths (polyps) that can lead to it, it's not always possible for everyone to have one. This study is exploring other options for early detection that are just as accurate. Researchers are collecting poo and blood samples to find special markers (proteins, also called biomarkers) that might show if someone has bowel polyps, bowel cancer, or a higher chance of getting them. By studying samples from people with and without these conditions, the team hopes to develop simpler, earlier tests to help prevent and detect bowel cancer.

At a glance

Status

Recruiting

Sponsor

University of Michigan Rogel Cancer Center

Enrolment target

1,200

Start

07 Aug 2019

Estimated completion

01 Mar 2028

Colonic Neoplasms

What is this study about?

Imagine being able to check for serious conditions like bowel cancer with a simple test, avoiding more invasive procedures for some. That's the aim of this important research. Bowel cancer is the second most common cancer in men and women in the UK. The good news is that if it's caught early, it can often be treated very successfully. Doctors currently use a test called a colonoscopy, where a camera looks inside your bowel, and this is still considered the best way to find bowel cancer and the small growths, called polyps, that can turn into cancer.

However, undergoing a colonoscopy isn't always easy or suitable for everyone due to various reasons like cost, time, or age. So, scientists are working hard to find other ways to detect bowel cancer and polyps early that are just as reliable. This study is focused on exploring these new options.

The main goal of this study is to see if looking at your poo or blood samples can help detect bowel cancers and polyps as early, or even earlier, than a colonoscopy. The researchers are particularly interested in finding specific 'markers' – these are tiny proteins or other substances in your body that could signal the presence of polyps, cancer, or an increased risk of developing them. By collecting samples from people who have cancer, polyps, or are at risk, they hope to get closer to offering simpler, non-invasive early detection methods.

Key takeaways

This study aims to find new, simpler ways to detect bowel cancer and polyps early.
It uses poo and blood samples to look for special 'markers'.
Early detection of bowel cancer means better treatment chances.
The research hopes to offer alternatives to colonoscopy for some people.
This is a research study; it doesn't offer direct medical recommendations or treatment.

Who may be eligible?

To take part in this study, you need to be at least 18 years old and willing to provide a blood sample (up to 60ml, which is about 4 tablespoons) and one or two poo samples. You also need to prepare a special poo test kit called a Fecal Immunochemical Test (FIT).

The study is looking for people who fall into several groups. This includes individuals who currently have bowel cancer that hasn't been treated yet, or those who have confirmed polyps in their bowel. They are also looking for people at higher risk, such as those with a past history of polyps or bowel cancer (more than three years ago), a family history of bowel cancer, or who have recently had a positive screening poo test but haven't had it investigated yet.

Finally, the study is also keen to include people who are considered to have an average risk of bowel cancer – meaning they have no history of bowel cancer or polyps and no family history of the disease. This broad range of participants helps the scientists compare samples from different groups to get the most accurate results.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Are you willing to provide blood and poo samples?
Do you currently have untreated bowel cancer or confirmed bowel polyps?
Do you have a personal history of bowel polyps or bowel cancer (more than 3 years ago)?
Do you have a family history of bowel cancer?
Are you considered to be at an average risk for bowel cancer, with no history of polyps or cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first need to sign a consent form, showing you understand what's involved and agree to participate. You would then be asked to provide between one and two poo samples, and complete a special at-home poo test kit called a Fecal Immunochemical Test (FIT). You would also need to have a blood sample taken, which would be up to 60ml (about four tablespoons). The study does not involve taking any medication. The exact number of visits or the total length of your participation is not specified, but it primarily involves providing these samples.

Potential risks and benefits

Potential benefits of participating include helping researchers develop easier and earlier ways to detect bowel cancer and polyps in the future, which could help many people. The main risks are the slight discomfort and potential bruising from giving a blood sample, and the time and effort involved in collecting poo samples. There are no direct medical recommendations as part of this study. You are always free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (13)

Cedars-Sinai Medical Center
Verified postcode
Los Angeles, United States· Recruiting
Carle Cancer Center
Verified postcode
Urbana, United States· Completed
Dana Farber Cancer Institute
Verified postcode
Boston, United States· Recruiting
University of Michigan
Verified postcode
Ann Arbor, United States· Recruiting
University of Minnesota
Verified postcode
Minneapolis, United States· Recruiting
NYU Langone Health
Verified postcode
New York, United States· Recruiting
University of North Carolina
Verified postcode
Chapel Hill, United States· Completed
Oregon Health and Science University
Verified postcode
Portland, United States· Recruiting
Hershey Medical Center
Verified postcode
Hershey, United States· Completed
M.D. Anderson Cancer Center
Verified postcode
Houston, United States· Recruiting
University of Washington
Verified postcode
Seattle, United States· Recruiting
Flinders Medical Center
Verified postcode
Adelaide, Australia· Recruiting

Common questions

What is a 'biomarker'?

A biomarker is a natural signal in your body, like a protein, that can tell doctors if you have a disease or are at risk of getting one.

What is a colonoscopy?

A colonoscopy is a medical procedure where a thin, flexible tube with a camera is used to look inside your large bowel to check for problems.

What are polyps?

Polyps are small growths on the lining of your bowel. Some polyps can turn into cancer over time, so finding them early is important.

Will I get my results from this study?

The study aims to develop new tests, but it's not designed to give you individual results about your health. Always discuss concerns with your own doctor.

Who is funding this research?

This research is part of a larger effort by the National Cancer Institute (NCI) in the US, through its Early Detection Research Network (EDRN).

How to find out more

Cancer AnswerLine

canceranswerline@med.umich.edu 1-800-865-1125 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.